ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN M

Recall Insight

This FDA Devices action (record #Z-2507-2014) was formally reported on September 10, 2014, with the manufacturer initiating the action on May 20, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Customed, Inc is listed as the recalling firm, operating out of Fajardo, PR. Federal records indicate 3 lots, 402 units ( multiple units per lot) units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.