FDA Medical devices recall ·
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF recall
- Recall number
- Z-0177-2025
- Date
- (initiated September 4, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1506 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PACK, REF DYNJ42884; h) RFT D & C PACK, REF DYNJ50851; i) KIT OB, REF DYNJ906623; j) D AND C, REF DYNJ907957A; k) CHS OB PACK III, REF DYNJCH907
Why was it recalled?
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
a) REF DYNJ0912449M, UDI/DI 40889942437536 (each), 10889942437535 (case), Lot Numbers: 23LBP185; b) REF DYNJ17309G, UDI/DI 40193489277181 (each), 10193489277180 (case), Lot Numbers: 24ABB399; c) REF DYNJ34268D, UDI/DI 40193489821421 (each), 10193489821420 (case), Lot Numbers: 23LBM844; d) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23LBS099; e) REF DYNJ34274B, UDI/DI 40889942642244 (each), 10889942642243 (case), Lot Numbers: 23KBB869; f) REF DYNJ39668I, UDI/DI 40195327456284 (each), 10195327456283 (case), Lot Numbers: 23LBM868; g) REF DYNJ42884, UDI/DI 40888277011077 (each), 10888277011076 (case), Lot Numbers: 23KBB574; h) REF DYNJ50851, UDI/DI 40889942029014 (each), 10889942029013 (case), Lot Numbers: 23LBL975; i) REF DYNJ906623, UDI/DI 40193489794695 (each), 10193489794694 (case), Lot Numbers: 24ABE587; j) REF DYNJ907957A, UDI/DI 40195327189854 (each), 10195327189853 (case), Lot Numbers: 24BBA954; k) REF DYNJCH907, UDI/DI 40193489391979 (each), 10193489391978 (case), Lot Numbers: 24ABC904
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0177-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.