Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11

FDA device recall Z-1770-2019 · posted 2019-07-11 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

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 taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FPA

Quantity affected

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

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,

Date initiated

2019-05-06

Date posted

2019-07-11

Date terminated

2021-07-19

Location

Franklin Lakes, NJ

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