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ARROW

TELEFLEX INCORPORATED · Model IPN032635 · UDI-DI 00801902005243

GBW Prescription

510(k) clearances

124

Adverse events (6 deaths)

Recalls

Facilities

Description

Peritoneal Lavage Kit

Recalls

Date	Firm	Reason
2026-04-21	ARROW INTERNATIONAL, LLC	Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2017-12-12	Boston Scientific Corporation	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2016-06-27	ConMed Corporation	The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
2015-10-14	Teleflex Medical	The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and inser
2012-07-20	Teleflex Medical	Product is missing the label on the internal packaging.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.