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Recall Observatory FDA recall evidence

Device product

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor

Z-2096-2023

May 25, 2023

Class II

Product summary

Firm
TELEFLEX LLC
Event
Event 92416
Status
Ongoing
Classification
Class II
Quantity
170 units
Official record key
device-enforcement:Z-2096-2023

Official wording

Reason: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Code information: Lot Numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1

Distribution pattern: Nationwide and Australia, Canada, S. Korea, Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).