FDA Medical Device Recalls (openFDA)
COVIDIEN LLC: Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Recall number
- Z-0015-2019
- Recalling firm
- COVIDIEN LLC
- Product
- Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Status
- Terminated
- Initiated
- 2018-08-01
- Posted
- not on file
- Terminated
- 2020-06-03
- Reason
- Potential for product sterility breach due to a compromised or pinched seal defect
- Root cause
- Nonconforming Material/Component
- Action
- On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions: 1. Inspect stock and quarantine affected product. 2. Immediately stop using affected product. 3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent further notices. 4. Notify any customers to whom you may have distributed product affected by this recall. 5. Contact the appropriate Customer Service group to arrange for credit and return of any affected product you may have: Hospital 800-964-5227 Federal Government 800-444-1166 Distributors800-635-6021 All other customers 888-444-5440 Customers with any questions regarding this letter may call (800) 292-9332.
- Quantity
- 2,730,821 units in total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: 18E030462,18E223262,18F122962
- 510(k) numbers
- ["K990530"]
- PMA numbers
- not on file
- Product code
- NAD
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28