FDA Device recall Z-2416-2014
PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAP…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAP… 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-2416-2014 |
| 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
PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAPE TOP WI ADHESIVE (1) TABLE COVER REINF. L/Free (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) CATHETER 14FR ROBIN NELAT PVC (2) GOWN LGE SMS IMPERVIOUS REINF. 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 900-1871, 1 lots: 111072025 |
|---|
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-2416-2014%22
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