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Recall Observatory FDA recall evidence

Device 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.

Z-1273-2013

April 15, 2013

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 64898
Status
Terminated
Classification
Class II
Quantity
150 Cases (75,000 Units)
Official record key
device-enforcement:Z-1273-2013

Official wording

Reason: 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.

Code information: Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.

Distribution pattern: US Distribution to the state of VA only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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