PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in
Summary
The FDA issued a Class II for PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0( by Ethicon, Inc.. Reason: Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximati.
Details
Source
Device Recall
External ID
Z-1571-2023
Action Date
2023-05-17
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH
Quantity Affected: 1,656 eaches (OUS only)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-31
Company
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 160 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-1571-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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