Covidien
Provision · Model ONB5SHF · UDI-DI 00810041639073
NLM
Prescription
1
510(k) clearances
468
Adverse events (1 deaths)
12
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-19 | Stryker Sustainability Solutions | Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall ex |
| 2016-11-11 | Stryker Sustainability Solutions | An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use. |
| 2015-07-10 | Stryker Sustainability Solutions | Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packa |
| 2015-06-01 | Stryker Sustainability Solutions | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical |
| 2015-06-01 | Stryker Sustainability Solutions | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical |
| 2015-06-01 | Stryker Sustainability Solutions | Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical |
| 2015-03-20 | CooperSurgical, Inc. | The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off a |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2010-07-09 | Ethicon Endo-Surgery Inc | The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product wil |
| 2008-03-11 | Ascent Healthcare Solutions, Inc. | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.