FDA Medical devices recall ·
Medline Convenience kits used for various procedures: 1) LINE INSERTION… recall
- Recall number
- Z-1593-2025
- Date
- (initiated March 3, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3808 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ82437A; 5) C LINE INSERTION CDS, Model Number: CDS980379J; 6) BSHR PICC LINE-LF, Model Number: DYNJ24529M; 7) ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; 8) PICC LINE PACK, Model Number: DYNJ55170F; 9) LINE INSERTION PACK, Model Number: DYNJ44949C; 10) RFA PACK, Model Number: DYNJ67899A; 11) KIT CENTRAL LINE INSERTION-LF, Model Number: PHS902533005; 12) INFANT LUMBAR PUNCTURE TRAY, Model Number: DYNDH1904; 13) PICC PACK-LF, Model Number: DYNJ55356A; 14) GENERAL TRAY, Model Number: DYNJ15652M; 15) CVR ENDOVENOUS PACK, Model Number: DYNJ80643; 16) LINE INSERTION TRAY, Model Number: DYNJ20803D
Why was it recalled?
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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
1) DYNJ44949C, UDI-DI: 10193489769227(each), 40193489769228(case), Lot Number: 24IBS279; 2) DYNJ41682C, UDI-DI: 10198459085512(each), 40198459085513(case), Lot Number: 24JBM452; 3) DYNJ81267A, UDI-DI: 10195327352356(each), 40195327352357(case), Lot Number: 24JBO094; 4) DYNJ82437A, UDI-DI: 10198459111006(each), 40198459111007(case), Lot Number: 24JBT077; 5) CDS980379J, UDI-DI: 10195327054908(each), 40195327054909(case), Lot Number: 24JBT886; 6) DYNJ24529M, UDI-DI: 10193489678284(each), 40193489678285(case), Lot Number: 24JBT947; 7) DYNJ65827, UDI-DI: 10193489298499(each), 40193489298490(case), Lot Number: 24JBW632; 8) DYNJ55170F, UDI-DI: 10195327614652(each), 40195327614653(case), Lot Number: 24KBB128; 9) DYNJ44949C, UDI-DI: 10193489769227(each), 40193489769228(case), Lot Number: 24KBB902; 10) DYNJ67899A, UDI-DI: 10198459071485(each), 40198459071486(case), Lot Number: 24KBC476; 11) PHS902533005, UDI-DI: 10889942043927(each), 40889942043928(case), Lot Number: 24KBD388; 12) DYNDH1904, UDI-DI: 10195327463779(each), 40195327463770(case), Lot Number: 24KBD507; 13) DYNJ55356A, UDI-DI: 10193489646191(each), 40193489646192(case), Lot Number: 24KBE301; 14) DYNJ15652M, UDI-DI: 10198459169410(each), 40198459169411(case), Lot Number: 24KBE666; 15) DYNJ80643, UDI-DI: 10195327055790(each), 40195327055791(case), Lot Number: 24KBH524; 16) DYNJ20803D, UDI-DI: 10889942553884(each), 40889942553885(case), Lot Number: 24KBJ200
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
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-1593-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.