FDA Enforcement Class I Terminated

PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE TOWEL/WRAP (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TUBE SUCTION CONNECT. }4" X 12' LIF (1) SURGICAL BLADE #11 CARBON STEEL (1 ELASTIC BANDAGE 6" X 5 YRD. L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall: Z-2386-2014 · Reported September 10, 2014

Enforcement

Recall Number: Z-2386-2014
Event ID: 68536
Classification: Class I
Status: Terminated
Product Type: Devices
Firm: Customed, Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: September 10, 2014
Initiation Date: May 20, 2014
Classification Date: August 29, 2014
Termination Date: August 14, 2017
Address: Calle Igualdad Final #7, Fajardo, PR, 00738, United States

Description

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.

Code Info

Product code 900-1298, 15 lots: 112041185 112062555 112072865 113015632 113026067 113026165 113026272 113036748 113047122 113057832 113078568 113089184 113109720 140111149 140211639

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.

Quantity

15 lots; 860 units (multiple units per lot)