Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Endovascular AAA Pack, ESED52B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3227-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Endovascular AAA Pack, ESED52B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Labor And Delivery KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3228-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Arthroscopy Pack, MSKA45A; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3229-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Open Shoulder, LWOS39L; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3230-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Day Surgery General Pack, FHGE18T; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3231-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Shoulder, SESH18I; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3232-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3233-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3234-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
IR Procedure Pack, CEAT19W; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3235-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Neuro Vascular, ANKV91A; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Neurological TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3236-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Hand Pack, AKHD97C; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3237-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Vaginal Delivery, ASDV25B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Labor And Delivery KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3238-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Cath Lab Pack, CECL02P; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Cardiac Catheterization KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3239-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Laparoscopy KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3240-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
ENT, COEN27N; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3241-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Nasal Sinus Pack, MTSN26B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3242-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Cysto, FTCY03L; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Endoscope Introducer KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3243-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 7, 2024
Pacemaker, COPM11B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Root cause: Under Investigation by firm
Recalling firm: American Contract Systems, Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.Recall #Z-3244-2024 Open, ClassifiedPosted Sep 24, 2024·Initiated Sep 11, 2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Reason: Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
Root cause: Under Investigation by firm
Recalling firm: Waldemar Link GmbH & Co. KG (Corp. Hq.)Type: Orthopedic Manual Surgical InstrumentDistribution: US Nationwide distribution in the states of FL, KS, MI, NJ, VA.Recall #Z-3245-2024
Open, ClassifiedPosted Sep 24, 2024·Initiated Aug 1, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria.
Catalog Number: 443624
Reason: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: System, Test, Automated, Antimicrobial Susceptibility, Short IncubationDistribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic Ecuador, Egypt, El Salvador, Ethiopia, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal
Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore,
South Africa, South Korea, Spain, Sri Lanka, Switzerland, Syrian Arab, Republic Taiwan, Tanzania, United Republic of Thailand, Timor-Leste, Trinidad And Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, Vietnam, Zambia, Zimbabwe.Recall #Z-3246-2024