TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY recall
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction…
Why was TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY recalled?
The firm received a complaint of an open pouch which breaches the sterilization validation.
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?
Part #: TLC200 & TLC300
- Product
- TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction…
- Recalling firm
- Applied Medical Technology Inc
- Quantity
- 3,754 Units
- Distribution
- Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
- Recall date
- May 11, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)