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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