Device recalls

Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fl…

BD SWITZERLAND SARL · Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh i…

Open, ClassifiedProcess controlZ-1944-2024
Open FDA's page for this record
Cfres ID
207285
Product res number
Z-1944-2024
Event date initiated
2024-04-18
Event date posted
2024-05-31
Recall status
Open, Classified
Res event number
94479
Product code
FPA
Code info
Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368
Firm FEI number
3012798826
Recalling firm
BD SWITZERLAND SARL
Address 1
17 terre bonne park a4 route de crassier
City
Eysins
Country
Switzerland
Additional info contact
Laura Corrado 267-810-4653
Root cause description
Process control
Product quantity
11.300 sets
Distribution pattern
Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.
Product description

Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.

Reason for recall

Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

Action

On 04/18/2024, the firm sent an URGENT: MEDICAL DEVICE PRODUCT RECALL" Letter via FedEx Express Saver to customer informing them that BD has received customer reports of the Alaris" Pump Infusion Set Low Sorbing Tubing (PE Lined) drip chamber becoming detached from the tubing for the catalog number and lot number referenced above. BD has confirmed that this issue is isolated to catalog number, 10013072 only and a single lot (no. 22115368) where mis-assembly of the drip chamber to the tubing occurred. Customers are instructed to: 1. Ensure the contents of this Product Recall communication are read and understood by those within their organization. 2. Immediately review their inventory for Catalog Number 10013072, Lot number 22115368. Destroy all unused product subject to the recall following their institution s process for destruction. 3. Notify all entities of this recall to whom the affected product may have been transferred. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form, whether or not they have any of the impacted material, so that BD may acknowledge your receipt of this notification and process their request for replacement product. For questions or assistance - contact: North American Regional Complaint Center - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com for Product Complaints or Technical Questions. Field Actions/Recalls - Email:BDRC18@BD.com for Recall related questions.

K numbers
K022209
Harmonized identifiers (openFDA)
Device name
Set, Administration, Intravascular
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2
K number
K791930, K942349, K854636, K001832, K854435, K960771, K904217, K210381, K840619, K820747, K810365, K860616, K942271, K911443, K101958, K811110, K234129, K984561, K990288, K860605, K123868, K171957, K895109, K182897, K854754, K011003, K910695, K952392, K893120, K974163, K882007, K901729, K053106, K873729, K010197, K790574, K013104, K963659, K041410, K864164 +1,136 more
Registration number
1030451, 3004111573, 3027327302, 9680448, 2523167, 9681413, 1319211, 1647137, 3016472589, 3007185216, 1410248, 3013820501, 3014732157, 1000595987, 3007305485, 1450662, 3008588205, 9612152, 1643059, 2528981, 3008650117, 3006260740, 3005941719, 1000587249, 3012461127, 3030989877, 3011237770, 3009746061, 3008808123, 3013517171, 3006158088, 3006942524, 3008132411, 3005405146, 2245270, 3007007790, 3007616112, 3043226252, 3019807891, 1000324175 +391 more
FEI number
1030451, 3004111573, 3027327302, 2523167, 1319211, 1000306431, 3016472589, 3002808169, 3007185216, 1410248, 3013820501, 3014732157, 1000112877, 1000595987, 3007305485, 1450662, 3008588205, 1643059, 2528981, 3006260740, 3008650117, 1000587249, 3012461127, 3030989877, 3002808374, 3011237770, 3009746061, 3008808123, 3013517171, 3006158088, 3006942524, 3008132411, 3005405146, 2245270, 3007007790, 3007616112, 3043226252, 3019807891, 1000136269, 1000324175 +391 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.