PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718),
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Company is recalling PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kits due to a potential safety defect. The tubing in these devices near the Luer or Y site may develop cracks or breaks. If cracked or broken, the tubing can leak, exposing patients to chemotherapy drugs or blood and other biohazard materials. These cracks could lead to blood loss, blocked catheters, air entering the bloodstream, interrupted medication delivery, or infection at the infusion site.
Approximately 5.3 million units of this product have been distributed worldwide under multiple catalog numbers and lot numbers. The recall affects specific catalog numbers including CPA00001, CPA00002, CPA00028, CPA00032, CPA00033, CPA00036, CPA00051, CPA00055, and CPA00056, with numerous lot numbers listed. The source does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution Quantity: 5,296,132 total Lot/code info: Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), CPA00055 UDI 00801741182181), CPA00056 (UDI 00801741182907). Lot Numbers: REEN0212 REEP2685 REEP3660 REEQ3563 REER1968 REDZ0705 REEP3313 REEP3547 REER0577 REEN0214 REEQ3569 REDY3552 REEN1934 REEP3280 REEP3552 REER1115 REEN0218 REEP3659 REEP1436 REER0298 REER1335 REDY0992 REEN0278 REEP1437 REEQ0232
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.