Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
C-SECTION PACK, Model Nos LLCS44F
LLCS44F-01
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cesarean Section TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1336-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
LAPAROSCOPY PACK, Model Nos LLLA21J
LLLA21J-02
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Laparoscopy KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1337-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
LABOR & DELIVERY PACK, Model Nos LLLD19H
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Labor And Delivery KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1338-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
OPEN HEART ADULT - SIDE A
, Model Nos LLOH01I-01
LLOH01I
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1339-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
GENERAL ANGIO PACK
, Model Nos
LLAP75G
LLAP75G-01
LLAP75G-02
LLAP75G-03
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1340-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
BORN ON ARRIVAL KIT
, Model No LLBN11B
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Labor And Delivery KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1341-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
C-SECTION PPS
, Model No LLCI66M
LLCI66M-02
LLCI66M-03
LLCI66M-04
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cesarean Section TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1342-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
CENTRAL LINE PICC
, Model No LLCL44H
LLCL44H-01
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Port Introducer KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1343-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
LABOR & DELIVERY PPS
, Model No LLLD64O
LLLD64O-01
LLLD64O-02
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Labor And Delivery KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1344-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
URO ROBOTIC PACK
, Model No LVUR44C
LVUR44C-03
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: General Surgery TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1345-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
CYSTO
, Model No SACY80R
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Endoscope Introducer KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1346-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
TOTAL HIP PACK
, Model No SMTH06O
SMTH06P
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Orthopedic TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1347-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
DELIVERY PACK
, Model No SGDV22D-01
SGDV22E
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Labor And Delivery KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1348-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
LACERATION TRAY
, Model No SGLA07A
SGLA07B-01
SGLA07B-02
SGLA07B
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: General Surgery TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1349-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
LACERATION TRAY
, Model No SGLA07A
SGLA07B-01
SGLA07B-02
SGLA07B
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: General Surgery TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1350-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
EAR PACK
, Model No SFEA12A
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1351-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
LAPAROSCOPY PACK
, Model No SFLA02A
SFLA02B
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Laparoscopy KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1352-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
CV BASIC PUMP PACK
, Model No WECV23D
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1353-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
DIAGNOSTIC NEURO IR TRAY
, Model No WENE21
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Neurological TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1354-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
NEURO IR TRAY
, Model No WENI56J
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Neurological TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1355-2025