FDA recall Z-1571-2023

Product

PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

Reason for recall

Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

Distribution

International distribution in the countries of United Kingdom, Ireland and Turkey.

Key facts

Status

Ongoing

Initiation date

2023-03-31

Report date

2023-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1571-2023