FDA Device recall Z-2408-2014
CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET… 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-2408-2014 |
| 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
CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED L/F (3) DRAPE SHEET 41" X 58" SMS LIF (1) BABY BLANKET PRINTED LIF (1) BOWL PLASTIC 80oz WITH LID (1) TUBE SUCTION CONNECT.%" X 12' LIF (15) LAP SPONGES PREWASH XRD LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) PAD OBSTETRICAL X-LARGE ST. L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) SYRINGE 20cc SITIP LIF (1) FEEDING TUBE 8FR. 15" LONG (1) BABY BEANNIES LIF (1) DRESSING ISLAND 4" X 14" (1) DRAPE C-SECTION WITH POUCH 102" X 121" X 78" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" L/F (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SUTURE BAG FLORAL LIF (1) UMBILICAL CORD CLAMP (1) BLADE SURGICAL #20 CARBON STEEL (1) WRAPPER 24" X 24" L/F 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 900-1719, 23 lots: 111082259 111092364 111123379 112010086 112020404 112041199 112051873 11206244…Product code 900-1719, 23 lots: 111082259 111092364 111123379 112010086 112020404 112041199 112051873 112062447 112125292 113015635 113026050 113036756 113057398 113067894 113078273 113088759 113099390 113109748 131210760 140111171 140211792 140312084 140412458 |
|---|
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-2408-2014%22
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