Medline brand medical procedure convenience kits recall: Sterility Concern
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF…
Why was Medline brand medical procedure convenience kits 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) DYNJ42735A, UDI/DI 40888277226433 (each), 10888277226432 (case), Lot Numbers: 23LBP975; b) DYNJ43457, UDI/DI 40888277055309 (each), 10888277055308 (case), Lot Numbers: 23LBS052; c) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 24ABF270; d) DYNJ46717A, UDI/DI 40193489650014 (each), 10193489650013 (case), Lot Numbers: 23LBO013; e) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 24ABC805; f) DYNJ53205B, UDI/DI 40193489424851 (each), 10193489424850 (case), Lot Numbers: 23LBN742; g) DYNJ57895, UDI/DI 40889942790372 (each), 10889942790371 (case), Lot Numbers: 23KBF265; h) DYNJ62803, UDI/DI 40193489688994 (each), 10193489688993 (case), Lot Numbers: 23LBN303; i) DYNJ64376, UDI/DI 40193489807845 (each), 10193489807844 (case), Lot Numbers: 24ABD094; j) DYNJ66619A, UDI/DI 40195327427840 (each), 10195327427849 (case), Lot Numbers: 23LBU414; k) DYNJ68030, UDI/DI 40193489469289 (each), 10193489469288 (case), Lot Numbers: 23LBL117; l) DYNJ68062, UDI/DI 40193489474580 (each), 10193489474589 (case), Lot Numbers: 24ABC304; m) DYNJ84997, UDI/DI 40195327444212 (each), 10195327444211 (case), Lot Numbers: 23LBK468
- Product
- Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1048 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)