FDA Device recall Z-0398-2015
Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture remova…
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture remova… by Customed, citing significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0398-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-10-08 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | FL, NY, PR |
Product
Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Identifiers
| code_info | Lot numbers 140412700 140412908 140613778 140714305 140814550 140915204 |
|---|
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-0398-2015%22
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