—#129146

Product

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

FDA product code: OEQ — Angiography/Angioplasty Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Product code 900-210, 30 lots: 112030717 112041290 112041446 112051934 112072622 112093725 112114388 112114598 113015442 113015630 113036436 113036760 113047216 113057458 113057699 113057816 113068045 113068165 113078572 113089023 113099285 113109786 131110235 131110605 131210967 140111414 140211876 140312332 140412833 140513348

Why it was 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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-20
Posted by FDA: 2014-08-29
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.