FDA Device recall Z-0244-2015
Uretheral Catheter Tray, Catalog number 900-278
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of Uretheral Catheter Tray, Catalog number 900-278 by Customed, citing customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0244-2015 |
| 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
Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason
Customed products are being recalled because of 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: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083…Lot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160 |
|---|
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-0244-2015%22
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