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Recall Observatory FDA recall evidence

Device product

Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

Z-3147-2024

July 18, 2024

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 95186
Status
Ongoing
Classification
Class II
Quantity
89 units
Official record key
device-enforcement:Z-3147-2024

Official wording

Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Code information: a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027

Distribution pattern: US, Colombia, Philippines, Russia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.