Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reported: December 10, 2014 Initiated: October 8, 2014 #Z-0311-2015
Product Description
Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for Recall
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Details
- Recalling Firm
- Customed, Inc
- Units Affected
- 625
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Location
- Fajardo, PR
Frequently Asked Questions
What product was recalled? ▼
Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.. Recalled by Customed, Inc. Units affected: 625.
Why was this product recalled? ▼
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Critical. Recall number: Z-0311-2015.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11