FDA Recall Terminated

Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.

Recall: Z-1770-2019 · Initiated May 6, 2019

Recall

Recall Number: Z-1770-2019
Event Number: 82752
Firm: Becton Dickinson & Company
FEI Number: 2243072
Product Code: FPA
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: May 6, 2019
Posted: July 11, 2019
Terminated: July 19, 2021
Address: 1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

Reason

An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

Action

The firm, BD, sent "Urgent Medical Device Recall" letters dated 5/6/19 to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately review your inventory for the specific model codes and lot numbers listed in the Affected Product Table. Destroy all product subject to the recall based on the affected product table -following your institutions process for destruction. 2. BD is instructing customers to discard all model codes and lot numbers with an expiration date between and including 05/2019 and 08/2020 in addition to the Affected Product List in this communication. 3. Share the recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 4. Until all affected product has been discarded and is no longer in use, please follow the instruction below: During infusion of critical medications, check the medication bag more frequently than normal to ensure that the remaining volume corresponds to the expected delivery time. 5. As always, review and follow the Instructions for Use provided with the product and the Alaris System, which includes the following: After the infusion set is loaded into the pump with the door closed, open the roller clamp and verify that no fluid is dripping through the drip chamber. If drips are observed, do not initiate infusion with the Pump Module unit and infusion set. Ensure that the clamp on the Alaris Pump Module Infusion Set is closed whenever infusion is not intended. 6. Any case of over-infusion or other serious or unexpected medical device incidents in patients receiving infusions with these Infusion Sets should be reported to Becton Dickinson. When reporting, please identify the model code and lot number to aid in the investigation process. 7. Complete the attached Customer Response Form and return to the BD contact noted on the form whether you have any of the impacted

Distribution

Worldwide Distribution; US (nationwide distribution) to following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, ID, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico; and countries of: Australia, Belgium, Canada, Chile, Malaysia, Mexico, Panama, Singapore and Taiwan.

Quantity

17992 lots of Infusion Sets totaling 183,572,651 units (Updated 8/26/19)