PlainRecalls
FDA Devices Critical Class I Terminated

Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24" (8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18" X 18" XRD Pro

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2516-2014

Product Description

Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24" (8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18" X 18" XRD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason for Recall

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.

Details

Recalling Firm
Customed, Inc
Units Affected
6 lots/ 1140 units, multiple units per lot
Distribution
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.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled? ▼
Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24" (8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18" X 18" XRD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 6 lots/ 1140 units, multiple units per lot.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2516-2014.

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