Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE

Summary

The FDA issued a Class II for Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, M by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..

Details

Product Description

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

Lot/Code Info: 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

Quantity Affected: 3808 units

Reason for Recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-03

Company