Ethicon, Inc. recalls PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft…
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
Read the official notice →- Date
- 2023-05-17
- Country
- United States
- Brand
- Ethicon
- Product
- PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft…
- Classification
- Class II
- Units
- International distribution in the countries of United Kingdom, Ireland and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Some applicator tips from these lots had open seals.
FDA · DeviceEthicon, Inc.US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY,…Official notice →- 2024-04-24
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Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM)…
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- 2023-09-27
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ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50,…
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- 2022-12-21
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Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
FDA · DeviceEthicon, Inc.International (OUS) only: Canada, Japan, Australia and New ZealandOfficial notice → - 2022-11-09
- US
Ethicon, Inc. recalls STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures…
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
- 2022-09-28
- US
Ethicon, Inc. recalls PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Product may contain the incorrect material which could impact treatment.
Other drugs & medical recalls in the United States
- 2023-05-17
- US
Medtronic Sofamor Danek USA Inc recalls Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal…
Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.
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Technidata S.A. recalls TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology,…
In a specific use case, when printing labels for slides, some labels may display wrong information
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New Wave Endo-Surgical, Corp. recalls M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
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FDA · DeviceNew Wave Endo-Surgical, Corp.US Nationwide distribution in the states of FL, MA, and GA.Official notice → - US
Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during…
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
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