FDA recall Z-1340-2018

Product

PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle

Reason for recall

Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.

Distribution

Distribution US Nationwide, Canada, India, and Colombia.

Key facts

Status

Terminated

Initiation date

2018-01-10

Report date

2018-04-18

Termination date

2019-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1340-2018