FDAFDA · Food and drugs·Recall number Z-2349-2014
CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH 4" (1) NEEDLE HYPODERMIC 25G X 5/8 (2) BLADE SURGICAL #15 STAINLESS STEEL (2) TOWEL CLOTH HUCK BLUE LIF (1) PADDING CAST COTTON ROLL 2" X 4yds (1) STOCKINETTE 6" X 48" L/F (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) DRAPE UTILITY LIF (1) GOWN SURG. FABRIC REINFORCED X-LARGE AAMI Ill LIF (1) TIME OUT BEACON NON WOVEN (1) HAND DRAPE ORTHOARTSO 76" X 150" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) BAG SUTURE FLORAL L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGEL TOWEL/WRAP L/F 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 900-742A, 4 lots: 140312026 140412702 140513380 140513481
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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