Class II Recall

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardi

Summary

The FDA issued a Class II for PDS II (polydioxanone) Suture - Intended for use in general soft tissue approxim by Ethicon, Inc.. Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection ..

Details

Source

Device Recall

External ID

Z-2146-2024

Action Date

2024-06-26

Status

Ongoing

Product Description

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H

Lot/Code Info: GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

Quantity Affected: 56952 units

Reason for Recall

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Distribution

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-05-10

Company

Ethicon, Inc.

Raritan, NJ

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 115 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Ethicon, Inc. have FDA actions?

Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2146-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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