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High RiskFDAfda-Z-3107-2017PRODUCT QUALITY

Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I...

Units Affected
184,102
Recall Date
August 1, 2017
Issuing Agency
Hazard
Product Quality

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3107-2017.

The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3107-2017.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Cardinal Health 200, Llc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3107-2017.

Cardinal Health 200, LLC

FDA

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Cardinal Health 200, Llc Recall FAQ

Cardinal Health 200, Llc is the subject of a medical implants safety report: Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I.... The notice was published on August 1, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 184,102 units are potentially affected.