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MEDLINE INDUSTRIES, LP - Northfield recalls Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY
Recalled February 15, 2023 · FDA recall Z-1093-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. · FDA Class II
Units
1,258 cases (2,154 units)
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Description
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Product
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →