PlainRecalls
FDA Devices Moderate Class II Terminated

PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable

Reported: April 24, 2019 Initiated: March 12, 2019 #Z-1136-2019

Product Description

PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable

Reason for Recall

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

Details

Recalling Firm
Ethicon, Inc.
Units Affected
550,681 eaches (WW) Total
Distribution
Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
Location
Somerville, NJ

Frequently Asked Questions

What product was recalled? ▼
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. Recalled by Ethicon, Inc.. Units affected: 550,681 eaches (WW) Total.
Why was this product recalled? ▼
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1136-2019.

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