Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Cle
FDA device recall Z-0724-2017 · posted 2016-12-08 · Terminated
Recall details
- Recalling firm
- Halyard Health, Inc
- Reason for recall
- 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.
- Action taken
- Accounts were notified of the recall by letter on 11/9/2016. The consignees were instructed to quarantine and discontinue use of the recalled lots and to discard/destroy per the facility's standard disposal procedure for nonwoven materials. A response form was included which was to be sent back.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 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
- Date initiated
- 2016-11-09
- Date posted
- 2016-12-08
- Date terminated
- 2017-02-22
- Location
- Alpharetta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPUNGUARD PLUS SURGICAL DRAPE (K862801) | Kimberly-Clark Corp. | 1986-08-07 |