Recall Z-2369-2014— 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: LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F (1) TABLE COVER 44" X 90" (1) MAYO STAND REINFORCED L/F (1) SURGICAL BLADE # 11 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F (1) TUBE SUCTION CONNECTING W' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF (1) CEF AZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL 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.