[Recalled] Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. — Recall initiated d

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Customed, Inc

• Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. — Class II
• Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF (2) — Class I
• Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. — Class I
• Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. — Class I
• LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GO — Class I
• LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) L — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.