Recall Z-2426-2014— 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: SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70" X 100" SMS LIF (1) CUP SPECIMEN WITH CAP 4oz (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) SKIN MARKER WITH RULER (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) BAG SUTURE FLORAL LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 21G X 1% LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE SPINAL ANESTH. 18G X 3% LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) DRAPE BEACH CHAIR SHOULDER ARTHROSC. (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (2) GAUZE SPONGE 4" X 4" 16PL Y XRD L/F Product Usage: 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.