FDA Device recall Z-0238-2015
Irrigation Tray With Bulb Syringe, Catalog number 900-020
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of Irrigation Tray With Bulb Syringe, Catalog number 900-020 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-0238-2015 |
| 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
Irrigation Tray With Bulb Syringe, Catalog number 900-020. 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: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062…Lot numbers: 111112971 111123273 112010006 112020294 112030797 112041052 112041386 112041450 112051644 112062300 112083043 112093635 113025799 113025979 113026274 113036446 113046993 113047330 113057829 113068135 113078452 113078659 113099261 131110143 140111104 140211714 140312032 140412568 140513034 140613550 140814606 140815025 |
|---|
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-0238-2015%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.