FDAClass IIFebruary 26, 2020

1 STRATAFIX" Spiral PDS Plus Violet 12" recall

1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

Why was 1 STRATAFIX" Spiral PDS Plus Violet 12" recalled?

The product do not meet certain internal testing specifications.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN: 10705031235816 Lot Number: PAH166 Expiration Date: 12/31/2020

Product
1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
Recalling firm
Ethicon, Inc.
Quantity
133 units
Distribution
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls