FDA Device recall Z-2390-2014
VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1)…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1)… 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-2390-2014 |
| 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
VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 36" (1) IMP. STOCKINETTE 14" X 48" LIF 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 900-1401, 3 lots: 109050994 110020540 110081960 |
|---|
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-2390-2014%22
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