FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Recall number
- Z-2234-2021
- Recalling firm
- Medline Industries Inc
- Product
- Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Status
- Terminated
- Initiated
- 2021-07-01
- Posted
- not on file
- Terminated
- 2023-03-02
- Reason
- The kits may contain an expired component.
- Root cause
- Employee error
- Action
- Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.
- Quantity
- 286 total kits for all products
- Distribution
- US Nationwide distribution in the states of MN, NE, and PA.
- Lot, serial or model codes
- Lot 19IBR389, Exp. 2020-09-30, GTIN (01)10889942833290.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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