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Formed Irrigating Cystotomes
STERIMEDIX LIMITED · Model M3610B-02SP/100 · UDI-DI 45056030402829
MED
Prescription
10
510(k) clearances
1,870
Adverse events (3 deaths)
21
Recalls
36
Facilities
Description
27g x 5/8" Cyst Fmd
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2018-07-13 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. |
| 2016-08-02 | Best Sanitizers Inc | Certain lots of the acid solution in Acecide-C are degrading faster than normal. |
| 2015-12-04 | Steris Corporation | The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Qui |
| 2015-08-10 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality o |
| 2015-07-27 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life. |
| 2013-03-04 | Steris Corporation | During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review proces |
| 2012-08-10 | Steris Corporation | STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design |
| 2012-08-01 | Steris Corporation | The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates result |
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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.