Class 2 Device Recall MediChoice Umbilical cord clamp

• Date Initiated by Firm: April 15, 2013
• Date Posted: May 08, 2013
• Recall Status: Terminated on August 10, 2015
• Recall Number: Z-1273-2013
• Recall Event ID: 64898
• Product Classification: Clamp, umbilical - Product Code HFW
• Product: Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
• Code Information: Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.
• FEI Number: 1451040
• Recalling Firm/ Manufacturer: Cypress Medical Products LLC; 1202 S Il Route 31; Mchenry IL 60050
• For Additional Information Contact: Mr. Michael Morzuch; 815-322-4981
• Manufacturer Reason for Recall: Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: Cypress Medical Products sent an "Urgent Voluntary Medical Device Recall" notification and an associated response form dated April 15, 2013 to their only customer for this device - Owens & Minor. The product problem was identified and recommended actions provided.
• Quantity in Commerce: 150 Cases (75,000 Units)
• Distribution: US Distribution to the state of VA only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.