Medline brand medical procedure convenience kits recall: Sterility Concern
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF…
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?
1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714; 3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332; 4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736; 5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713; 6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628; 7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108; 8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028; 9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976; 10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507; 11) REF DYNJ48978C, UDI/DI 40195327325948 (each) 10195327325947 (case), Lot Numbers: 23LBP883; 12) REF DYNJ50428C, UDI/DI 40195327504039 (each) 10195327504038 (case), Lot Numbers: 23LBN301; 13) REF DYNJ53418B, UDI/DI 40195327372270 (each) 10195327372279 (case), Lot Numbers: 23LBO773; 14) REF DYNJ55479D, UDI/DI 40195327416769 (each) 10195327416768 (case), Lot Numbers: 23LBL444; 15) REF DYNJ58445A, UDI/DI 40195327585953 (each) 10195327585952 (case), Lot Numbers: 23LBU911; 16) REF DYNJ58566B, UDI/DI 40195327243228 (each) 10195327243227 (case), Lot Numbers: 23KBC919; 17) REF DYNJ59431, UDI/DI 40888277741257 (each) 10888277741256 (case), Lot Numbers: 24ABG210; 18) REF DYNJ60077A, UDI/DI 40193489862905 (each) 10193489862904 (case), Lot Numbers: 23LBO542; 19) REF DYNJ62111C, UDI/DI 40195327312146 (each) 10195327312145 (case), Lot Numbers: 23LBP204; 20) REF DYNJ65830A, UDI/DI 40195327588732 (each) 10195327588731 (case), Lot Numbers: 23LBR366; 21) REF DYNJ66821A, UDI/DI 40193489974929 (each) 10193489974928 (case), Lot Numbers: 23KBQ852; 22) REF DYNJ68883, UDI/DI 40193489848329 (each) 10193489848328 (case), Lot Numbers: 23KBC527; 23) REF DYNJ69729, UDI/DI 40193489973267 (each) 10193489973266 (case), Lot Numbers: 24ABD664; 24) REF DYNJ80004, UDI/DI 40195327005192 (each) 10195327005191 (case), Lot Numbers: 23LBP094; 25) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 24ABG464; 26) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 23LBU050; 27) REF DYNJ82626, UDI/DI 40195327199488 (each) 10195327199487 (case), Lot Numbers: 24ABN216; 28) REF DYNJ83155, UDI/DI 40195327236855 (each) 10195327236854 (case), Lot Numbers: 23LBV474; 29) REF DYNJ900583M, UDI/DI 40195327061853 (each) 10195327061852 (case), Lot Numbers: 24ABU214; 30) REF DYNJ905569B, UDI/DI 40193489995672 (each) 10193489995671 (case), Lot Numbers: 24ABJ966; 31) REF DYNJ907541A, UDI/DI 40195327054268 (each) 10195327054267 (case), Lot Numbers: 23KBT202; 32) REF LLSCASET01, UDI/DI 40080196120681 (each) 10080196120680 (case), Lot Numbers: 23LBM079; 33) REF SYNJ910011B, UDI/DI 40195327246809 (each) 10195327246808 (case), Lot Numbers: 24ABS212
- Product
- Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 5972 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)