Alaris recallZ-1968-2020 · Bd Switzerland Sarl · initiated Apr 9, 2020

Why it was recalled

The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

FDA root cause category: Under Investigation by firm

What the company is doing

URGENT MEDICAL DEVICE RECALL BD Alaris PCEA Administration Set and BD Alaris PCEA Administration Kit letters dated 4/9/20 were distributed to customers. Please Take the Following Actions: 1. Immediately review your inventory for the Catalog and Lot Numbers specified in this notification and discard all product subject to the recall. 2. Share this recall notification with any users of the product, within your facilities, to ensure they are also aware of this recall. 3. As a direct replacement will not be available for the foreseeable future, complete the attached Customer Response Form and return to the BD contact noted on the form. Please indicate whether you have any of the impacted product so that BD may acknowledge your receipt of this notification and process your credit. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Distributor Notice Please Take the Following Actions: 1. Immediately review your inventory for the Catalog and Lot Numbers specified in this notification and return all product subject to the recall to BD following the Packing Instructions enclosed. 2. Identify all your customers that purchased any affected product, as defined in this recall notification. Email an excel file listing of all customers to [email protected] within 72 hours of receipt of this letter so that BD may notify customers directly. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether you have any of the impacted product so that BD may acknowledge your receipt of this notification and process your credit accordingly. 4. A copy of the customer communication is attached for your reference. Actions to be taken by BD: 1. BD will prov

Recall details

Recall number

Z-1968-2020

Status

Terminated

Initiated by the company

Apr 9, 2020

Recalling firm

Bd Switzerland Sarl

Quantity

110,350

Product code

FPA

FDA submissions

K811885

Distribution

Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.

Product description

BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Alaris 10800177

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall1 report

Product lines

• AlarisBD Switzerland Sàrl · 85 models · 2,797 reports · 10 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 85525).

• Z-1967-2020 · Terminated
  BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stri…