Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Recall
- Recall Number
- Z-2525-2014
- Event Number
- 68536
- Firm
- Customed, Inc Calle Igualdad Final # 7
- FEI Number
- 2648727
- Product Code
- LRO
- Status
- Terminated
- Root Cause
- Package design/selection
- Initiated
- May 20, 2014
- Posted
- August 29, 2014
- Terminated
- August 14, 2017
- Address
- Fajardo, PR, 00738
Description
Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" 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.
2 lots/ 35 units, multiple units per lot