ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125" X 85" SMS (1) DRAPE LASER CAMERA W/EL (3) TOWELS ABSORBENT 15" X 20" LIF (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL (1) BABY BLANKET IMP. POLY ABS. LIF (1) NEEDLE HYPODERMIC 20G X 1%'' (10) GAUZE SPONGES 4" X 4" 16PLY (1) BLADE SURGICAL #11 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) IMPERVIOUS STOCKINETTE (1) SHEET DRAPE 42" X 55" LIF (1) SUTURE BAG FLORAL LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) MAYO STAND COVER REINFORCED LIF (2) GOWN IMPERVIOUS REINFORCED SMS LARGE (4) STRIPS TAPE (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Recall
- Recall Number
- Z-2368-2014
- Event Number
- 68536
- Firm
- Customed, Inc Calle Igualdad Final # 7
- FEI Number
- 2648727
- Product Code
- FWZ
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- May 20, 2014
- Posted
- August 29, 2014
- Terminated
- August 14, 2017
- Address
- Fajardo, PR, 00738
Description
ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125" X 85" SMS (1) DRAPE LASER CAMERA W/EL (3) TOWELS ABSORBENT 15" X 20" LIF (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL (1) BABY BLANKET IMP. POLY ABS. LIF (1) NEEDLE HYPODERMIC 20G X 1%'' (10) GAUZE SPONGES 4" X 4" 16PLY (1) BLADE SURGICAL #11 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) IMPERVIOUS STOCKINETTE (1) SHEET DRAPE 42" X 55" LIF (1) SUTURE BAG FLORAL LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) MAYO STAND COVER REINFORCED LIF (2) GOWN IMPERVIOUS REINFORCED SMS LARGE (4) STRIPS TAPE (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP 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.
12 lots; 432 units (multiple units per lot)