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Recall Observatory FDA recall evidence

Device product

PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle

Z-1339-2018

January 10, 2018

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 79541
Status
Terminated
Classification
Class II
Quantity
72
Official record key
device-enforcement:Z-1339-2018

Official wording

Reason: 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.

Code information: Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590

Distribution pattern: Distribution US Nationwide, Canada, India, and Colombia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.