Recall Z-1357-2025
American Contract Systems Inc · initiated February 6, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Codes / lots: UDI-DI 00191072147196 Lots 941241 899241 70-050873 70-051230 70-051578 70-052009A 70-052884
Reason for recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA-determined cause: Process control
Action taken
The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
Details
- Recall number
- Z-1357-2025
- Initiated
- February 6, 2025
- Posted by FDA
- March 14, 2025
- Product code
- LRO – General Surgery Tray
- Quantity
- 534 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Recalling firm
- American Contract Systems Inc, Tiffin, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1331-2025 Class II | LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1332-2025 Class II | DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1333-2025 Class II | HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1334-2025 Class II | MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1335-2025 Class II | CYSTO PACK , Model N. HKCY31AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1336-2025 Class II | C-SECTION PACK, Model Nos LLCS44F LLCS44F-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1337-2025 Class II | LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1338-2025 Class II | LABOR & DELIVERY PACK, Model Nos LLLD19HACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1339-2025 Class II | OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01IACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1340-2025 Class II | GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1341-2025 Class II | BORN ON ARRIVAL KIT , Model No LLBN11BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1342-2025 Class II | C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1343-2025 Class II | CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1344-2025 Class II | LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1345-2025 Class II | URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1346-2025 Class II | CYSTO , Model No SACY80RACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1347-2025 Class II | TOTAL HIP PACK , Model No SMTH06O SMTH06PACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1348-2025 Class II | DELIVERY PACK , Model No SGDV22D-01 SGDV22EACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1349-2025 Class II | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1350-2025 Class II | LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1351-2025 Class II | EAR PACK , Model No SFEA12AACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1352-2025 Class II | LAPAROSCOPY PACK , Model No SFLA02A SFLA02BACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1353-2025 Class II | CV BASIC PUMP PACK , Model No WECV23DACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1354-2025 Class II | DIAGNOSTIC NEURO IR TRAY , Model No WENE21ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1355-2025 Class II | NEURO IR TRAY , Model No WENI56JACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1356-2025 Class II | AV FISTULA , Model No UTAV77TACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1358-2025 Class II | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1359-2025 Class II | OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1360-2025 Class II | SPINE LUMBAR PACK , Model No UTSL72AA UTSL72ABACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |
| Z-1361-2025 Class II | THORACIC PACK , Model No UTTC82Y UTTC82AA-01ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of… | 02/06/2025Open, Classified |