Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported September 5, 2012
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Access Systems recalled 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an A… - a low-severity action.
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an A… was recalled by Bard Access Systems in September 5, 2012. Reason: Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they w…. Check the official notice for the remedy. Verify recall #Z-2277-2012 with the FDA Devices before acting.
The recall
Bard Access Systems issued this low-severity FDA Devices recall-Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they w….
- Low
- severity level
- 120 units
- affected scope
- Class III
- classification
- September 5, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2277-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2277-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on August 7, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Bard Access Systems is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 120 units.
The documented reason for this recall is: Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013. Distribution data in the federal record shows the product reached: National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.. 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.
Medical Devices recalls over time
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
120 units
Related Recalls
6
3 from same agency
Product description
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.
Reason for recall
Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2277-2012 |
| Date reported | September 5, 2012 |
| Date initiated | August 7, 2012 |
| Recalling firm | Bard Access Systems |
| Firm location | Salt Lake City, UT |
| Affected scope | 120 units |
| Distribution | National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR. |
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.
- Check the recall number (Z-2277-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.. Recalled by Bard Access Systems. Units affected: 120 units.
Why was this product recalled? ▼
Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2012. Severity: Low. Recall number: Z-2277-2012.
Where was the recalled product distributed? ▼
Distribution: National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2277-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 September 5, 2012. 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.