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PETERS SURGICAL · Model 31681 · UDI-DI 03661522008799

GAQ
1
510(k) clearances
936
Adverse events (7 deaths)
6
Recalls
74
Facilities

Recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2019-04-19Ethicon, Inc.Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
2019-04-19Ethicon, Inc.Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
2014-03-11Teleflex MedicalProduct does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
2014-03-11Teleflex MedicalProduct does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
2014-03-11Teleflex MedicalThe products are being recalled because they did not meet minimum diameter requirements.

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Data 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.