Reported Mar 8, 2023 · Ongoing

Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO*…

Covidien, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Lot codes and dates
  • GTIN20884521037868, 20884521036519, 20884523004387, 20884521036540, 20884521037868. Model Number Lot #
    • CP535
    • D2C1521Y
    • D2E1342Y
    • D2E1580Y
    • D2E2678Y
    • D2E2679Y
    • D2F0509Y
    • CP824
    • D2D0251Y
    • CP825
    • D2C3234Y
    • VP543
    • D2B1270Y
    • D2D1493Y
    • D2E1389Y
Amount recalled
8604 units

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.