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.
Recall
- Recall Number
- Z-2349-2014
- Event Number
- 68536
- Firm
- Customed, Inc Calle Igualdad Final # 7
- FEI Number
- 2648727
- Product Code
- OJH
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- May 20, 2014
- Posted
- August 29, 2014
- Terminated
- August 14, 2017
- Address
- Fajardo, PR, 00738
Description
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.
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.
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
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.
4 lots; 360 units (multiple units per lot)