Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Reported: February 15, 2023 Initiated: November 17, 2022 #Z-1089-2023
Product Description
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 194 cases (508 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 194 cases (508 units).
Why was this product recalled? ▼
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2023. Severity: Moderate. Recall number: Z-1089-2023.
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