Bard Peripheral Vascular Inc recalls Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff…
Reason for recall
Due to damage to outer tray that can potentially compromise the sterile barrier
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat60060UDI codeCatalog # Number241 affected lotsHUKV05476.6600100HUKU0307HUKW13126.6600120HUKU0274
+233 more
600310HUKS0783HUKU0250HUKU0310600350HUKR1359HUKS0811HUKU03164.2600520HUKS1468HUKU0246HUKU0278HUKU0289HUKU0305HUKU0327HUKU0338HUKU0353HUKW0164HUKW1278HUKW12856.6600540HUKR0064HUKR0065HUKR0067HUKU0252HUKU0270HUKU0279HUKU0308HUKU0334HUKV0359HUKV0550HUKV0560HUKW0156HUKW01599.6600560HUKS0776HUKS0816HUKS1220HUKU0302HUKU0311HUKU0345HUKU0350HUKV0376HUKV0555600570HUKR1342HUKR1344HUKR1346HUKR1347HUKR1348HUKR1356HUKR1363HUKR1367HUKR1368HUKS0774HUKU0238HUKU0242HUKU0247HUKU0253HUKU0254HUKU0266HUKU0280HUKU0283HUKU0284HUKU0290HUKU0293HUKU0294HUKU0298HUKU0312HUKU0339HUKU0340HUKU0344HUKU0354HUKV0549HUKV0569HUKV0576HUKV0581HUKW0148600620HUJY0302HUJY1095HUJZ1332HUJZ1336HUJZ1339HUJZ1340HUKR1349HUKR1364HUKS0784HUKS0806HUKS1217HUKS1218HUKU0259HUKU0351HUKV0349HUKV0567HUKW053412.5600650HUKQ0535HUKS1474HUKS1483HUKU0313HUKU0317HUKU0328HUKV0354HUKV0371HUKW0171HUKW1283606560HUKR1370HUKS1219HUKU0255HUKU0324HUKV0578HUKW0172HUKW13156.60600100CEHUKU0307HUKW13120600310CEHUKS0783HUKU0250HUKU03104.20600520CEHUKS1468HUKU0246HUKU0278HUKU0289HUKU0305HUKU0338HUKU0353HUKW0164HUKW1278HUKW12856.60600540CEHUKR0064HUKR0065HUKR0067HUKU0252HUKU0270HUKU0279HUKU0308HUKU0334HUKV0359HUKV0550HUKW0156HUKW01599.60600560CEHUKS0776HUKS0816HUKS1220HUKU0302HUKU0311HUKU0345HUKU0350HUKV05550600570CEHUKR1342HUKR1344HUKR1346HUKR1347HUKR1348HUKR1356HUKR1363HUKR1367HUKR1368HUKS0774HUKU0238HUKU0242HUKU0247HUKU0253HUKU0254HUKU0266HUKU0280HUKU0283HUKU0284HUKU0290HUKU0293HUKU0294HUKU0298HUKU0312HUKU0339HUKU0340HUKU0344HUKU0354HUKV0549HUKV0576HUKW01480600620CEHUJY0302HUJY1095HUJZ1332HUJZ1336HUJZ1339HUJZ1340HUKR1349HUKR1364HUKS0784HUKS0806HUKS1217HUKS1218HUKU0259HUKU0351HUKV0349HUKV0567HUKW053412.50600650CEHUKQ0535HUKS1474HUKS1483HUKU0313HUKU0317HUKU0328HUKV0354HUKV0371HUKW0171HUKW12830606560CEHUKR1370HUKS1219HUKU0255HUKU0324HUKV0578HUKW0172HUKW1315
What the firm is doing
On 01/12/1026, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Removal" Letter informing customers that BD has identified via internal inspections that the packaging of some Hickman Catheter and Broviac Catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier. Affected products were distributed between 06/12/2025 to 11/28/2025. Customers are instructed to: 1. Discontinue use of product listed in the letter 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. If the affected products have been distributed further, forward this notification to ensure that these entities are contacted and informed of the recall. 3. 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 required product credit. 4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For questions or assistance, contact: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
DistributionShow detailsHide
Worldwide - U.S. Nationwide distribution including in the states of 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, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1367-2026
- FDA 510(k) clearance · K830233The device's official FDA premarket clearance record
- FDA 510(k) clearance · K830256The device's official FDA premarket clearance record
- FDA device classification · LJSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5970The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Bard Peripheral Vascular IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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