MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE IN…
- Recall date
- March 3, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1593-2025
- FDA classification
- Class II
- Brand / firm
- MEDLINE INDUSTRIES, LP - Northfield
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Why it was recalled
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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