| | Class 2 Device Recall leg bag |  |
| Date Initiated by Firm | June 02, 2017 |
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| Create Date | August 10, 2017 |
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| Recall Status1 |
Terminated 3 on July 26, 2021 |
| Recall Number | Z-2872-2017 |
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| Recall Event ID |
77733 |
| Product Classification |
Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
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| Product | 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. |
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| Code Information |
Product Code 151919; Lot No. NGAS4058 |
| FEI Number |
1018233
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Recalling Firm/
Manufacturer |
C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington
GA
30014-1497
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| For Additional Information Contact |
770-784-6120 |
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Manufacturer Reason
for Recall | Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier. |
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FDA Determined
Cause 2 | Process control |
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| Action | Bard Medical a Medical Device letter dated June 2, 2017 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The notification requests that consignees examine inventory and identify any product on hand. The firm indicates that product return is not required, but customers are encouraged to call 1-800-526-4455 if product doesn't meet their needs or if they have any questions regarding the recall. If product was further distributed, the firm requests that the provided recall notification be forwarded to the respective organization. |
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| Quantity in Commerce | 2,350 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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