Home › Device types › GBZ
Catheter, Cholangiography
FDA product code GBZ · Class 1 · General, Plastic Surgery
148
Registered devices
381
Adverse events
27
Recalls
24
510(k) clearances
Devices with this code
Reddick Scoop Tip Cholangiogram Catheter — Lemaitre Vascular, Inc.Kumar Clamp® — NASHVILLE SURGICAL INSTRUMENTS, LLCPVC Thoracic Catheters — Atrium Medical CorporationCook — COOK INCORPORATEDMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.PVC Thoracic Catheters — Atrium Medical CorporationTAUT — TELEFLEX INCORPORATEDGore TIPS® Sheath — CREGANNA UNLIMITED COMPANYPVC Thoracic Catheters — Atrium Medical CorporationPVC Thoracic Catheters — Atrium Medical CorporationPVC Thoracic Catheters — Atrium Medical CorporationFranklin — COOK INCORPORATEDPMI — PROGRESSIVE MEDICAL, INC.PMI — PROGRESSIVE MEDICAL, INC.Metal Catheter — RZ-Medizintechnik GmbHSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.PMI — PROGRESSIVE MEDICAL, INC.TAUT — TELEFLEX INCORPORATEDPVC Thoracic Catheters — Atrium Medical CorporationOlsen — COOK INCORPORATEDPVC Thoracic Catheters — Atrium Medical CorporationOperative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle — FLEXBAR MACHINE CORPORATIONPVC Thoracic Catheters — Atrium Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-07 | Atrium Medical Corporation | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. |
| 2026-08-07 | Atrium Medical Corporation | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. |
| 2026-08-07 | Atrium Medical Corporation | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. |
| 2023-09-29 | Atrium Medical Corporation | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. |
| 2022-04-21 | Atrium Medical Corporation | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expirat |
| 2018-10-12 | Atrium Medical Corporation | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at th |
| 2017-01-20 | Atrium Medical Corporation | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| 2017-01-20 | Atrium Medical Corporation | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
| 2016-10-26 | Atrium Medical Corporation | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. |
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