Reported Nov 11, 2015 · Terminated
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St · Tempe, AZ · 85281-2438
Is this the product you have?
- FLAIR Endovascular Stent Graft
- Product Code
FAS08070FAF08070
- Implant Size8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section
- Lot codes and dates
- Product CodeFAF08070, Lot No.
152 of 152 codes
ANWJ3216ANXD0762ANXI2396ANYG0316ANWJ3217ANXD1279ANXI3475ANYG0654ANWK0056ANXD1280ANXJ1793ANYG1630ANWK0057ANXD1641ANXJ2700ANYG3413ANWK0058ANXD1642ANXK0641ANYG3414ANWK0567ANXD1643ANXK3033ANYH0028ANWK0568ANXD1644ANXL0612ANYH0029ANWK0569ANXD2494ANXL0947ANYH0982ANWK0570ANXD2495ANXL1451ANYH0983ANWK0571ANXD2496ANXL1752ANYH2304ANWK0572ANXD2992ANXL1865ANYH3647ANWK2441ANXD2993ANYA0042ANYI2267ANWK2442ANXD2994ANYA0050ANYI2914ANWK2443ANXE0280ANYA0933ANYJ0077ANWK2444ANXE0281ANYA1633ANYJ1318
- ANXD0761 ANXI2395 ANYF3184 Product CodeFAS08070 Lot No.
137 of 137 codes
ANWJ3097ANXC2796ANYA0036ANYK2342ANWJ3098ANXC2797ANYA0037ANYK3044ANWJ3099ANXD0029ANYA0939ANZB1349ANWK0580ANXD0030ANYA2054ANZB1350ANWK0581ANXD0031ANYA2678ANZB1351ANWK0582ANXD0032ANYA3222ANWK0583ANXD2812ANYB0453ANWK1097ANXD4188ANYB1024ANWK1098ANXD4189ANYB2414ANWK1099ANXD4607ANYB3174ANWK1100ANXE1146ANYB3177ANWK1101ANXE1147ANYB3178ANWK2446ANXE1465ANYC0218ANWK2447ANXE1466ANYC1998ANWK3392ANXE3173ANYC2328ANWK3393ANXF0156ANYD2752ANWK3394ANXF1333ANYD3371ANWK3570ANXF2407ANYE0228ANWK3571
- Product CodeFAF08070, Lot No.
- Amount recalled
- 292 units
Where it was sold
- Nationwide
Why it was recalled
Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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