Home › Device types › EXB
Collector, Ostomy
FDA product code EXB · Class 1 · Gastroenterology, Urology
1,484
Registered devices
543
Adverse events
5
Recalls
102
510(k) clearances
Devices with this code
New Image — HOLLISTER INCORPORATEDNew Image — HOLLISTER INCORPORATEDSenSura Mio Convex brand logo — Coloplast A/SAssura — Coloplast A/SAssura — Coloplast A/SBrava — Coloplast A/SAssura — Coloplast A/SAssura — Coloplast A/SNew Image — HOLLISTER INCORPORATEDAssura — Coloplast A/SSenSura Mio — Coloplast A/SSenSura Mio — Coloplast A/SSenSura Mio Convex — Coloplast A/SPremier — HOLLISTER INCORPORATEDBrava — Coloplast A/SSenSura Mio Convex — Coloplast A/SSenSura Click — Coloplast A/SNew Image — HOLLISTER INCORPORATEDSenSura Mio Convex brand logo — Coloplast A/SSecuri-T — HOLLISTER INCORPORATEDSenSura Mio — Coloplast A/SPouchkins — HOLLISTER INCORPORATEDSecuri-T — HOLLISTER INCORPORATEDSenSura Click — Coloplast A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-07-27 | Coloplast Manufacturing US, LLC | On July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these resu |
| 2011-06-22 | Convatec Inc. | Post-operative kits 57 mm may contain 70 mm pouches. |
| 2011-02-01 | Convatec Inc. | Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, l |
| 2008-03-07 | ConvaTec | Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileosto |
| 2008-02-14 | ConvaTec | Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct. |
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