Recall Z-2344-2014— Customed, Inc

Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81" 2.1M REGULAR CLAM (1) NEEDLE HYPODERMIC 18G X 1 ~ (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SHEET DRAPE 70" X 100" LIF (1) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1 ) TUBE SUCTION CONNECT. X" X 12' LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1 ) DURAPREP SURGICAL SOLUTION 26ML LIF (1 ) NEEDLE SPINAL ANEST. 18G X 3 %" LIF (2) ELASTIC BANDAGE 6" X 5YRD. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) PAD ABDOMINAL 8" X 7.5" (1) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: 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..

Recalling firm

Customed, Inc

Classification

Class I

Status

Terminated

Initiated

2014-05-20

Terminated

2017-08-14

Firm location

Fajardo, PR, United States

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