BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Reported: November 27, 2019 Initiated: September 18, 2019 #Z-0504-2020
Product Description
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Reason for Recall
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Details
- Recalling Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Units Affected
- 582
- Distribution
- Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
- Location
- Glens Falls, NY
Frequently Asked Questions
What product was recalled? ▼
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 582.
Why was this product recalled? ▼
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0504-2020.
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