ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Recall
- Recall Number
- Z-2345-2014
- 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) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF 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.
1 lot; 120 units (multiple units per lot)