FDA Device recall Z-2576-2015
PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing,…
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing,… 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-2576-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-10 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | PR |
Product
PREMIUM LAPAROTOMY PK CUSTOMED 6/CS 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 | Code:9001296 Lots: 140915095 exp. 2/28/19 141115975 exp. 11/30/15 150116734 exp. 1/31/16 150116736 exp. 2/28/16…Code:9001296 Lots: 140915095 exp. 2/28/19 141115975 exp. 11/30/15 150116734 exp. 1/31/16 150116736 exp. 2/28/16 150116737 exp. 2/28/16 150116739 exp. 2/28/16 150116738 exp. 2/28/16 150116735 exp. 2/28/16 150217232 exp. 2/28/16 150217230 exp. 2/28/16 150217233 exp. 2/28/16 150217234 exp. 3/31/16 150217235 exp. 3/31/16 150217231 exp. 3/31/16 150317683 exp. 3/31/16 150317684 exp. 3/31/16 150317685 exp. 3/31/16 150317686 exp. 4/30/16 150317687 exp. 4/30/16 150418285 exp. 4/30/16 150418286 exp. 4/30/16 150418287 exp. 4/30/16 150418288 exp. 4/30/16 150418289 exp. 4/30/16 150518634 exp. 5/31/16 150518635 exp. 5/31/16 150519022 exp. 5/31/16 150519023 exp. 5/31/16 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2576-2015%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.