FDAFDA · Food and drugs·Recall number Z-2342-2014
0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (1) CORD UMBILICAL CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz (1) SET UP COVER CLEAR POLY (1) BASIN WASH 7QT. (1) ABDOMINAL DRAPE WITH TAPE LIF (2) KELLY FORCEP STRAIGHT 5 % (1) MAYO SCISSOR STRAIGHT 6% (1) BABY BEANNIES EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Published September 10, 2014 · Recall initiated: May 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Customed, Inc
- Distributor
- Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
- Lot
- Product code 900-645, 51 lots: 109030612 109030699 109051050 109051212 110061464 110071705 110081981 110082075 110092405 110112816 110122898 111010147 111020295 111030648 111041071 111051300 111061559 111071831 111092556 111102774 111112951 111112964 111123280 112010194 112010255 112030736 112052003 112083214 112093731 112104256 112114396 112125106 112125305 113015456 113025965 113036376 113047028 113057498 113078339 113078575 113099294 113099575 131110079 131110411 131110588 140111243 140211676 140211878 140412472 140412889 140513351
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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