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Catheter, Cholangiography

FDA product code GBZ · Class 1 · General, Plastic Surgery

148

Registered devices

378

Adverse events

Recalls

510(k) clearances

Devices with this code

Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Olsen — COOK INCORPORATED LAP CHOLANGIOGRAPHY CATHETER — RANFAC CORP.Metal catheter — RZ-Medizintechnik GmbH PVC Thoracic Catheters — Atrium Medical Corporation TAUT — TELEFLEX INCORPORATED Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.LAP-13-4 — FLEXBAR MACHINE CORPORATION Olsen — COOK INCORPORATED PVC Thoracic Catheters — Atrium Medical Corporation NA — Edwards Lifesciences LLC PVC Thoracic Catheters — Atrium Medical Corporation TAUT — TELEFLEX INCORPORATED Rapid Exchange — BOSTON SCIENTIFIC CORPORATION Kumar Clamp® for Single Port, Bariatrics and Robotics — NASHVILLE SURGICAL INSTRUMENTS, LLC COOK — COOK INCORPORATED TAUT — TELEFLEX INCORPORATED TAUT — TELEFLEX INCORPORATED Reddick Scoop Tip Cholangiogram Catheter — Lemaitre Vascular, Inc.TAUT — TELEFLEX INCORPORATED Olsen — COOK INCORPORATED Olsen — COOK INCORPORATED Cook — COOK INCORPORATED PVC Thoracic Catheters — Atrium Medical Corporation

Recent recalls

Date	Firm	Reason
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.
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.
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.