Open Heart Tray - Pack recall: Sterility Concern
OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2)…
Why was Open Heart Tray - Pack 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 900-170, 45 lots: 110102563 110112615 110123042 111010248 111020273 111041096 111051368 111061709 111071957 111082061 111082257 111092361 111092454 111102694 112010081 112020399 112030637 112041196 112051864 112062443 112072782 112093724 112125027 113015544 113025946 113026104 113036753 113047198 113057812 113068156 113078518 113088755 113089018 113089196 113099566 131110068 131110400 131110579 131210963 140111411 140211740 140312329 140412793 140513106 140513245
- Product
- OPEN HEART TRAY - PACK- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) TRAY PLATO LARGE (3) DRESSING NON ADH TELFA 8 X 3 (2) BAG GLASSINE PLAIN (2)…
- Recalling firm
- Customed, Inc
- Quantity
- 45 lots; 1292 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)