HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG (1) DRAPE UTILITY WITH TAPE (1) STOCKINETTE IMPERV. 14" X 48" (1) U-DRAPE 54 X 72 WITH TAPE SPLIT HIP DRAPE 89" X 128" WITH POUCH TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Recall Z-2438-2014 · Posted 2014-08-29
Advertisement
Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity4 lots/110 units, (multiple units per lot)
Reason for Recall
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.
Firm Action
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
Root Cause
Package design/selection
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement