Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repa

FDA device recall Z-1051-2023 · posted 2023-02-01 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

Action taken

On 01/04/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx or email to customers informing them that the firm has received complaints regarding hardened/coagulated adhesive associated with various Catheter Repair Kits. as a result of the hardened/coagulated adhesive, there is the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained, therefore potentially prolonging surgery or necessitating exchange. Customer are instructed to: 1. Discontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. 3. If customers purchased this product from a distributor, contact the distributor for further instructions and credit resolution. 4. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any applicable credit regarding impacted product. 5. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For Distributors (in addition to the above): Identify all customers within their distribution network that purchased any affected product and provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. Contact their BD representative if they require assistance with this process or they may also contact the number below for further assistance. North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LJS

Quantity affected

7520 (Breakdown: US 3764; OUS 3243)

Distribution

Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC

Date initiated

2023-01-04

Date posted

2023-02-01

Location

Tempe, AZ

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