Arthroscopy Pack recall: Sterility Concern
ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc…
Why was Arthroscopy 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 900-740, 20 lots: 112030744 112041351 112052010 112062505 112072876 112093641 112104101 112114588 112125111 113015457 113025967 113036380 113057877 113088887 113099452 113099576 131110272 131210839 140111248 140211735
- Product
- ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc…
- Recalling firm
- Customed, Inc
- Quantity
- 20 lots; 1356 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)