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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62780

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2012
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bard Access Systems

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2277-2012
Recall number
Z-2277-2012
Initiated
August 07, 2012
Classification
Class III
Status
Terminated
Recalling firm
Bard Access Systems
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code 5883730 lot number REVK0125.

Distribution pattern

National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.