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WECK
TELEFLEX INCORPORATED · Model IPN009317 · UDI-DI 34026704630401
HBO
Prescription
10
510(k) clearances
68
Adverse events
3
Recalls
31
Facilities
Description
RANEY CLIPS DISPOSABLE 10/pouch
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-01 | Integra LifeSciences Corp. | Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier |
| 2018-05-03 | Medtronic Neurosurgery | The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not u |
| 2017-12-20 | Medtronic Neurosurgery | Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.