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Lower risk Medical device recall · FDA · Published September 20, 2022

Teleflex Pocket Pac i.c. Catheter Kit Recall: Non-sterile Risk

Teleflex recalls non-sterile Pocket Pac i.c. catheter kits that could cause infection. Affected units have specific model and serial numbers. Contact Teleflex for replacement.

🇺🇸 FDA recall #Z-0227-2023Medical deviceTeleflex ›
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Contact the company

Recalling firmTELEFLEX LLC3015 Carrington Mill Blvd · Morrisville, NC 27560-5437
✎ GovInfoNow plain-language explainer

Teleflex is recalling a specific urinary catheter kit because it may not be sterile. This could lead to infections if used improperly. The recall affects certain model numbers sold with specific serial tags. Read more at govinfonow.com/recall/60035-teleflex-pocket-pac-i-c-catheter-kit-recall-non-sterile.

Source Summary by GovInfoNow · govinfonow.com/recall/60035-teleflex-pocket-pac-i-c-catheter-kit-recall-non-sterile · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0227-2023

Cite this page

“Teleflex Pocket Pac i.c. Catheter Kit Recall: Non-sterile Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60035-teleflex-pocket-pac-i-c-catheter-kit-recall-non-sterile. Based on FDA recall #Z-0227-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0227-2023%22&limit=1).

The FDA announced on 2022-09-20 that Teleflex LLC is recalling Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kits because the product may not be sterile.

How to tell if you have it

  • Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140
  • UPC 24026704323245

The hazard

The recalled urinary catheters may not be sterile, posing a potential infection risk.

Context

GovInfoNow's records show TELEFLEX LLC has issued 8 other recalls since 2022-08-29. In 2023-05-25, Teleflex recalled Preformed AGT Oral Endotracheal Tubes due to connector disconnection risk and Pilling Lowsley Prostatic Tractor CVD Retractors for incomplete cleaning instructions. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (2026-04-21), Medline Convenience Kits Recall (2026-01-07), and Stryker Daig Livewire Steerable Catheter Recall (2026-04-10).

How to tell if you have this one

Check for the model number 14 Fr (4.7mm) with serial tag UDI (01)24026704323245(17)250405(10)74E2200810. The product was sold with the reference number REF 10096140.

  • Brand
    Teleflex
  • Product
    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Serial

    Look for the serial tag UDI (01)24026704323245(17)250405(10)74E2200810 on the catheter kit.

Where it went and when

Where it was distributed

Distributed in 9 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “TN, CA, NC, TX, FL, OH, MO, IL, OR” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Illinois, Missouri, North Carolina, Ohio, Oregon, Tennessee, Texas.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Sep 20, 202212. FDA classified it Class II: Nov 11, 202223. Published in FDA’s Enforcement Report: Nov 23, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0227-2023 (September 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0227-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA