Gown Cool Impervious XLGE Breathable Customed recall: Sterility Concern
Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF…
Why was Gown Cool Impervious XLGE Breathable Customed recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code 900-2592, 20 lot: 112020341 112041064 112041312 112051974 112062485 112062496 112124666 112125076 113057401 113067920 113078313 113088800 113089085 113099304 113109818 131110252 131210794 140111212 140312135 140412659
- Product
- Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF…
- Recalling firm
- Customed, Inc
- Quantity
- 20 lots (1656 packed units, multiple units per lot)
- 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.
- Recall date
- September 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)