Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Recall
- Recall Number
- Z-2500-2014
- 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
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: 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.
3 lots/ 74 units, multiple units per lot