FDAFDA · Food and drugs·Recall number Z-2414-2014
ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" x 21 " (1) SHEET ARTRHOSCOPY "T" W/POUCH STD SMS (1) SUTURE BAG FLORAL (3) ABSORBENT TOWEL 15" X 20" 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 900-1832, 39 lots: 109122842 110010063 110020346 110030645 110051220 110071773 110082195 110092199 110102436 110112622 110122927 111010075 111030627 111041079 111051370 111071782 111082071 111092368 111102709 111113047 111123182 112020420 112030819 112041405 112051890 112072788 112083304 112083409 113026166 113036456 113036733 113047115 113047200 113078282 113088768 113099486 113099587 131010209 140111184
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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