Halyard C-Section Drape with Clear Screen and Full recall
Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise…
Why was Halyard C-Section Drape with Clear Screen and Full recalled?
Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.
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 44965 NS - Lot Numbers AC6174###, AC62266###, AC6229###, AC6243###, AC6252###; Product Code 44966 00 - Lot Numbers AC6146##L, AC6157##L, AC6177##L, AC6215##L, AC6221##L, AC6228##L, AC6245##L, AC6252##L, AC6258##L, AC6272##L, AC6277##L; Product Code 44967 NS - Lot Numbers AC6170###, AC6219###, AC6223###, AC6229###, AC625###; Product Code 44068 00 - Lot Numbers AC6146##L, AC6177##L, AC6230##L, AC6231##L, AC6234##L, AC6242##L, AC6245##L, AC6264##L, AC6271##L, AC6277##L; Product Code 44077 NS - Lot Numbers AC6170###, AC6213###, AC6214###, AC6222###, AC6223###, AC6251###; Product Code 44978 00 - Lot Numbers AC6147##L, AC6177##L, AC6243##L, AC 6252##L - (# = includes numbers 0, 1, 2, 3, 4, 5, 6, 7, 8 or 9 - L = includes letters a, b, or c)
- Product
- Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise…
- Recalling firm
- Halyard Health, Inc
- Quantity
- 132 cases
- Distribution
- US Nationwide Distribution in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, WY
- Recall date
- December 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)