FDA-Device2023-02-15Class II

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 PAC

Hazard

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sold states

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Affected count

1,258 cases (2,154 units)

Manufactured in

3 Lakes Dr, Northfield, IL, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1093-2023

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