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Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechan

FDA device recall Z-1273-2013 · posted 2013-05-08 · Terminated

Recall details

Recalling firm
Cypress Medical Products LLC
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.
Action taken
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.
Root cause
Unknown/Undetermined by firm
Status
Terminated
Product code
HFW
Quantity affected
150 Cases (75,000 Units)
Distribution
US Distribution to the state of VA only.
Date initiated
2013-04-15
Date posted
2013-05-08
Date terminated
2015-08-10
Location
Mchenry, IL

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