FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - SPT: Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
- Recall number
- Z-1472-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - SPT
- Product
- Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
- Status
- Open, Classified
- Initiated
- 2022-06-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- Kits contain leaking bottles of isopropyl alcohol
- Root cause
- Under Investigation by firm
- Action
- The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.
- Quantity
- 477 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Code: a. Model Number DYNJ0689093V, Lot Codes: 22DMI666, 21LBI103, 21HBO705, 21JBP781, 21JBQ762, 21FBG532, 21FBG535, b. Model Number DYNJ62927, Lot Numbers: 22BBB412
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGR
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- 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