FDA Device recall Z-2438-2014
HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRA…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRA… by Customed, citing customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2438-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | US |
Product
HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH POUCH TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Reason
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Identifiers
| code_info | Product code 900-2184, 4 lots 111041038 111071378 111082085 112062292 |
|---|
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-2438-2014%22
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