FDA Device recall Z-1440-2016
Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as w…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as w… by Customed, citing recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1440-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-07 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Customed |
| Distribution | PR |
Product
Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Identifiers
| code_info | LOTS: SL15195-01 (150619229) 31-JUL-16 SL15210 (150619392) 31-JUL-16 SL15211 (150619392) 31-JUL-16 SL15223 (1507197…LOTS: SL15195-01 (150619229) 31-JUL-16 SL15210 (150619392) 31-JUL-16 SL15211 (150619392) 31-JUL-16 SL15223 (150719733) 31-AUG-16 SL15224 (150719733) 31-AUG-16 SL15275 (150920795) 30-SEP-16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1440-2016%22
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