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U.S. Department of Health and Human Services

Class 2 Device Recall MediChoice Umbilical cord clamp

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  Class 2 Device Recall MediChoice Umbilical cord clamp see related information
Date Initiated by Firm April 15, 2013
Date Posted May 08, 2013
Recall Status1 Terminated 3 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.
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 2		 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.
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