Severity
Moderate
FDA Devices recall · Reported August 16, 2017
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
C.r. Bard, Inc. recalled BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and La… - a moderate-severity action.
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and La… was recalled by C.r. Bard, Inc. in August 16, 2017. Reason: Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's steril…. Check the official notice for the remedy. Verify recall #Z-2872-2017 with the FDA Devices before acting.
The recall
C.r. Bard, Inc. issued this moderate-severity FDA Devices recall-Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's steril….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2872-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2872-2017) was formally reported on August 16, 2017, with the manufacturer initiating the action on June 2, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. C.r. Bard, Inc. is listed as the recalling firm, operating out of Covington, GA. Federal records list the affected scope as 2,350 units.
The documented reason for this recall is: Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier. Distribution data in the federal record shows the product reached: US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
2,350 units
Related Recalls
6
3 from same agency
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2872-2017 |
| Date reported | August 16, 2017 |
| Date initiated | June 2, 2017 |
| Recalling firm | C.r. Bard, Inc. |
| Firm location | Covington, GA |
| Affected scope | 2,350 units |
| Distribution | US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 16, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.