Notice names this product. ARROW INTERNATIONAL’s PERCUTANEOUS SHEATH INTRODUCER with 7 is named in FDA Class II recall Z-1912-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Identifying details: Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130. Units affected: 115. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Company / brand: ARROW INTERNATIONAL recalls
Affected product: PERCUTANEOUS SHEATH INTRODUCER with 7 recall status
Official ID Z-1912-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.