Teleflex recalls Pilling Lowsley Prostatic Tractor Str (ref 243:201) due to incomplete pre-cleaning instructions in the manual. Affected units include specific lot numbers. Consumers should check their product details.
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Teleflex is recalling Pilling Lowsley Prostatic Tractor Str retractor models with lot numbers A6 through W1 because the instructions for pre-cleaning are incomplete. This could lead to improper cleaning and potential complications during medical procedures.
Incomplete pre-cleaning instructions could lead to improper cleaning of the device. This might increase the risk of infection or complications during medical procedures if the device is not cleaned properly.
Medical professionals using the Pilling Lowsley Prostatic Tractor Str retractor with specific lot numbers are likely affected. Patients undergoing procedures with this device may be at risk if the cleaning instructions are not followed correctly.
Check the lot number on the device, which should be one of A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, or W1. The product is a retractor used in medical procedures.
Look for the lot number on the device, which should be one of A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, or W1.
The recall is due to incomplete pre-cleaning instructions in the Instructions for Use (IFU), which could lead to improper cleaning and potential complications during medical procedures.
Lot numbers A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, and W1 are affected.
No, the recall does not require stopping use immediately. However, you should check the lot number and follow the cleaning instructions if they are incomplete.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-2097-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-2097-2023 from Teleflex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.