CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" (9) LABELS FOR SKIN MARKERS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Recall
- Recall Number
- Z-2449-2014
- 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
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" (9) LABELS FOR SKIN MARKERS 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/160 units,(multiple units per lot)