PlainRecalls
FDA Devices Moderate Class II Ongoing

MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D

Reported: December 11, 2024 Initiated: October 9, 2024 #Z-0647-2025

Product Description

MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D

Reason for Recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Details

Units Affected
478 units
Distribution
US Nationwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 478 units.
Why was this product recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0647-2025.