FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
- Recall number
- Z-0783-2021
- Recalling firm
- Medline Industries Inc
- Product
- Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
- Status
- Terminated
- Initiated
- 2020-11-13
- Posted
- not on file
- Terminated
- 2021-10-26
- Reason
- The cylindrical sponge component is not x-ray detectable.
- Root cause
- Process control
- Action
- Customers were notified by email on 11/13/2020. Customers are asked to return the response form via fax or email. The recalling firm will send subsequent letters to consignees that have not provided a response to the recall notification within the allotted time. No product is to be returned to Medline Industries. Consignees are instructed to apply labels to their affected kits and return to inventory. The label indicates that there is a recalled component within the pack, not to use it, and replace from a different sterile supply. No other components within the kit are affected.
- Quantity
- 360
- Distribution
- Foreign distribution only - Canada.
- Lot, serial or model codes
- Lot 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- 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