CollectEVAC recall: Sterility Concern
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The…
Why was CollectEVAC recalled?
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
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?
Lot numbers: M431760, M431710, M426580, M430200, M423010
- Product
- CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The…
- Recalling firm
- Civco Medical Instruments Inc
- Quantity
- 52 kits
- Distribution
- Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
- Recall date
- September 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)