—#203406

Product

LAVH, REF BBLV21C

FDA product code: OJF — Hysterectomy Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: UDI/DI 00191072166234, Lot Number 686221

Why it was recalled

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

Root cause (FDA determination)

Process control

Action the firm took

Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.

Recalling firm

Firm: American Contract Systems, Inc.
Address: 7802 E Telecom Pkwy, Temple Terrace, Florida 33637-0928

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, IA.

Timeline

Recall initiated: 2023-09-01
Posted by FDA: 2023-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203406. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.