C.R. Bard Recalls X-Force Nephrostomy Balloon Dilation Catheter Kits
C.R. Bard is recalling 192 units of X-Force Nephrostomy Balloon Dilation Catheter Kits because a contract manufacturer packaged an incorrect 30Fr sheath instead of the labeled 24Fr sheath.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging error (incorrect sheath size) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
C.R. Bard, Inc. is recalling 192 units of the X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm (Product Code 996081). The recall involves Lot BMZCE039 with an expiration date of December 31, 2018. The product is a dual lumen catheter with a balloon mounted on the distal tip, recommended for the dilation of the nephrostomy tract and placement of the working sheath.
The recall was initiated because a contract manufacturer packaged an incorrect sheath with the product. Specifically, a 30Fr sheath was packaged instead of the correct 24Fr sheath. This packaging error could result in the use of a device with different physical dimensions than intended for the procedure.
The affected units were distributed worldwide, including in the United States to California, Kansas, Missouri, New York, Virginia, and Washington, as well as to China, Italy, Sweden, and the United Kingdom. Healthcare providers and facilities that have received this product should stop using it and contact C.R. Bard for instructions on return or disposal.
The recalled product
- Product
- X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath…
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 192
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot BMZCE039
- Expiration Date 2018-12-31
Distribution
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