FDA Device recall Z-1477-2016
Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h… 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-1477-2016 |
| 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: 900547 BASIC SURGICAL PACK 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: SL15187 (150719805) 31-JUL-16 SL15245 (150820338) 31-AUG-16 SL15264 (150920833) 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-1477-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.