Laparoscopy Pack I recall: Sterility Concern
LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F (1)…
Why was Laparoscopy Pack I 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 900-2485 ,2 lots 112051964 113078524
- Product
- LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F (1)…
- Recalling firm
- Customed, Inc
- Quantity
- 2 lots/612 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)