Teleflex Pilling Surgical Retractor Recalled for Incomplete Cleaning Instructions
Teleflex recalls the Pilling LOWSLEY PROSTATIC TRACTOR STR due to incomplete pre-cleaning instructions in the product manual. The issue affects 32 units distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving incomplete labeling (pre-cleaning instructions) for a surgical medical device. While no illnesses or injuries have been reported, incomplete cleaning instructions present a risk-of-harm situation where improper sterilization could lead to patient infection. Per the rubric, risk-of-harm products without reported injury score at 3 (High).
Plain-English summary
Teleflex LLC has recalled the Pilling LOWSLEY PROSTATIC TRACTOR STR (model reference 243201), a surgical retractor intended for prostate procedures. The recall affects 32 units distributed to healthcare facilities nationwide and internationally, including Australia, Canada, South Korea, and Singapore.
The recall was issued due to incomplete pre-cleaning instructions in the Instructions for Use (IFU) accompanying the device. Proper cleaning instructions are essential for surgical instruments to ensure effective sterilization before patient use.
The FDA classified this as a Class II recall, indicating a potential risk situation where the device could cause adverse health effects but would not be likely to cause serious injury or death. Facilities and users in possession of affected lot numbers (A6, A7, A8, C3, C8, E6, G9, I8, I9, Q0, S2, W1) should contact Teleflex LLC for guidance on obtaining corrected instructions or arranging return of the device.
The recalled product
- Product
- Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
- Manufacturer
- TELEFLEX LLC
- Hazard
- incomplete-labeling
- sterilization-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lot Numbers: A6
- A7
- A8
- C3
- C8
- E6
- G9
- I8
- I9
- Q0
- S2
- W1
Distribution
Distributed nationwide across the United States.
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