Incision & Drainage Tray recall: Sterility Concern
Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
Why was Incision & Drainage Tray recalled?
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
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: 111123296 112030746 112124854 112124886 113036382 113088890 131110313 140412880 140613780 140915163
- Product
- Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
- Recalling firm
- Customed, Inc
- Quantity
- 9200
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Recall date
- December 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)