PlainRecalls
FDA Devices Critical Class I Terminated

ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8" STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION T

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2313-2014

Product Description

ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8" STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) NEEDLE HYPODERMIC 18G X 1 'h (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (2) UTILITY BOWL 16oz (3) BAND BAG WITH RUBBAND & TAPE LIF (25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) DRAPE ANGlO 75" X 145" (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF (1) SAFETY SCALPEL #11 LIF (1) GOWN STANDARD SMS LARGE VELCRO NECK (2) NEEDLE HYPODERMIC 23G X 1" (1) TRAY ORGANIZER FULL DEEP (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) LABEL FOR MEDICATION INTEGRILIN RED (1) PVP PAINT 8" STICK SPONGE 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
30 lots; 6500 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? ▼
ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8" STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) NEEDLE HYPODERMIC 18G X 1 'h (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (2) UTILITY BOWL 16oz (3) BAND BAG WITH RUBBAND & TAPE LIF (25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) DRAPE ANGlO 75" X 145" (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF (1) SAFETY SCALPEL #11 LIF (1) GOWN STANDARD SMS LARGE VELCRO NECK (2) NEEDLE HYPODERMIC 23G X 1" (1) TRAY ORGANIZER FULL DEEP (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) LABEL FOR MEDICATION INTEGRILIN RED (1) PVP PAINT 8" STICK SPONGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. Recalled by Customed, Inc. Units affected: 30 lots; 6500 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-2313-2014.

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