Z-2663-2020Class II

PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit...

Name: Z-2663-2020 PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit...
Creator: Becton Dickinson & Company
Published: 2020-06-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-06-19 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504)... on 2020-06-19. FDA classified it as Class II and gives the reason as "Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2663-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-19
Posted: 2020-07-20
Terminated: 2022-07-29
Recalling firm: Becton Dickinson & Co
Product: PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680)
Product code: PTI Non-Coring (Huber) Needle
Reason for recall: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: URGENT MEDICAL DEVICE RECALL notification letters dated 6/19/20 were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Immediately review your inventory for the specific catalog and lot numbers referenced in Attachment A. Discontinue use of those devices and destroy all product subject to this recall following your institutions process for destruction. MDS-20-1979 Page 2 of 28 BD Medical 1 Becton Drive Franklin Lakes, NJ 07417 USA bd.com 2. Share this notification with all users of the product within your facility network to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your credit accordingly for the discarded material. a. Customers who purchased product directly from BD will receive credit. b. Customers who did not purchase product directly from BD will need to contact their distributor to obtain credit. 4. Report any adverse health consequences experienced with the use of this product to BD at [email protected]. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1800FDA1088 (18003321088) Mail: MedWatch, HF2, FDA, 5600 Fishers Lane, Rockville, MD 208529787 Customer/Technical Support Phone: 8002901689 Monday Friday between 8:00 am to 5:00 pm MDT [email protected] An Urgent Medical Device Recall notification letter dated 8/25/20 was sent to customers informing them of two additional lots of affected product. An URGENT MEDICAL DEVICE RECALL UPDATE dated 10/7/20 was sent to customers informing them of two additional lots of affected product.
Quantity in commerce: 5,296,132 total
Distribution: Worldwide Distribution
Product codes and lots: Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680). Lot Numbers: REDY0771 REDY2980 REEN1111 REEN4550 REER0529 REEN2070 REEP0993 REDX0120 REDW1093 REDW2530 REDX1388 REDY0772 REEN1112 REEN2779 REEP2910 REEQ4095 REER2358 REDX0188

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2663-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2660-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2661-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2662-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2663-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2664-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2665-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2666-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2667-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2668-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2669-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2670-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2671-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18

Product code PTI

K153440Class IIPowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. / cleared 2016-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)