Home › Straub Medical AG › Collecting Bag 2000ml (Straub Medical®)

Collecting Bag 2000ml (Straub Medical®)

Straub Medical AG · Model Version 1.0 · UDI-DI 07640142810612

KNX Prescription

510(k) clearances

2,156

Adverse events

Recalls

125

Facilities

Description

The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag.

Recalls

Date	Firm	Reason
2026-06-25	C.R. Bard Inc	Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
2026-06-25	C.R. Bard Inc	Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
2023-12-04	Cardinal Health 200, LLC	Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2019-01-14	Teleflex Medical	The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label
2019-01-14	Teleflex Medical	The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label informa
2017-06-02	C.R. Bard, Inc.	Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
2016-07-11	C.R. Bard, Inc.	The product contained a latex catheter instead of a silicone catheter.
2016-06-29	C.R. Bard, Inc.	Labeling problem
2015-07-10	Customed, Inc	Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
2015-07-10	Customed, Inc	Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.