ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAPE UTILITY WITH TAPE L/F ( 1) DENTURE CUP WITH LID ( 1) UTILITY BOWL 16oz. (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F (4) RUBBER BAND ( 1) NEEDLE HYPODERMIC 27G X 1 Y.." ( 1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (3) CAP NURSE 21 " GREEN BOUFFANT (3) MASK SURGICAL BLUE 120MM HG LIF ( 1) PREPPING PAD WITH CUFF (2) TIP ABSORB. APPLIC. STICK SPONGE L/F ( 1) SCALPEL WEIGHTED SAFETY # 11 ( 1) PROBE DRAPE ST 6" X 96" NO GEL LIF ( 1) WRAPPER 30" X 30" (3) TOWELS ABSORBENT 15" X 20" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Recall
- Recall Number
- Z-2422-2014
- 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
ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAPE UTILITY WITH TAPE L/F ( 1) DENTURE CUP WITH LID ( 1) UTILITY BOWL 16oz. (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F (4) RUBBER BAND ( 1) NEEDLE HYPODERMIC 27G X 1 Y.." ( 1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (3) CAP NURSE 21 " GREEN BOUFFANT (3) MASK SURGICAL BLUE 120MM HG LIF ( 1) PREPPING PAD WITH CUFF (2) TIP ABSORB. APPLIC. STICK SPONGE L/F ( 1) SCALPEL WEIGHTED SAFETY # 11 ( 1) PROBE DRAPE ST 6" X 96" NO GEL LIF ( 1) WRAPPER 30" X 30" (3) TOWELS ABSORBENT 15" X 20" L/F 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.
12 lots; 190 units (multiple units per lot)