Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Strykeflow Electrocautery Probe

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Stryker Strykeflow Electrocautery Probe see related information
Date Initiated by Firm September 12, 2019
Create Date March 17, 2020
Recall Status1 Terminated 3 on October 31, 2022
Recall Number Z-1508-2020
Recall Event ID 85100
510(K)Number K963765  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971

These products are distributed with the following sheath/probe:
0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM
0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM
0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM
0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM
0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM
0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM
Code Information Lot codes: 010318 02 010318 03 010318 04 010318 05 010318 06 010318 07 010318 08 010318 10 010518 01 010518 02 010518 03 010518 04 010518 05 010518 06 010518 07 010518 08 010518 09 010518 10 011819 01 011819 04 011819 06 011819 07 011819 08 011819 09 011819 10 012219 01 012219 02 012219 03 012219 04 012219 05 012219 06 012219 07 012219 08 012219 09 012219 10 012219 12 021018 01 021018 02 021018 03 021018 04 021018 05 021018 07 021018 08 021018 09 021018 10 021018 11 021018 12 021018 13 021018 14 021018 15 021018 16 021018 17 021018 18 021018 19 022718 01 022718 02 022718 03 022718 04 022718 05 022718 06 022718 07 022718 08 022718 09 022718 10 022718 11 022718 12 022718 13 022718 14 022718 15 022718 18 022718 19 022718 20 070618 01 070618 02 070618 03 070618 04 070618 05 070618 06 070618 07 080416 02 080818 09 080818 10 081518 01 081518 02 081518 03 081518 04 081518 06 081518 07 083018 01 083018 02 083018 03 083018 04 083118 02 083118 04 083118 05 083118 07 083118 08 083118 09 083118 10 091318 01 091318 02 091318 03 091318 05 091318 06 091318 07 091318 08 091318 09 101018 01 101018 02 101018 03 101018 04 101018 05 101018 06 101018 07 101018 09 101018 10 110218 01 110218 02 110218 03 110218 04 110218 05 110218 06 110218 08 110218 09 110218 10 110507 02
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Brent Ladd
408-754-2000
Manufacturer Reason
for Recall		 Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
FDA Determined
Cause 2		 Other
Action On September 25, 2019 and November 26, 2019, the firm sent an "Urgent Medical Device Recall Notification" letter to all consignees via USPS mail. In addition, to informing consignees about the recall, they recall letter asked consignees to take the following actions: Actions to be taken by the Customer/User: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Check all stock areas and/or operating room storage to determine if any devices with the affected Strykeprobe Sheath lot numbers from Attachment A are at your facility. - a. If you would like a list of all affected probe lot numbers, please email EndoRecall@Stryker.com 3. If affected product is found, segregate the product and call Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). - a. Remove the affected sheath, quarantine, and discontinue use of the identified non-conforming recalled sheath(s). - b. When returning units, please enclose Business Reply Form on Attachment B. 4. If affected product is NOT found: - a. Please complete Business Reply Form on Attachment B and return to EndoRecall@Stryker.com 5. Please forward a copy of this letter to any other personnel within your facility you deem appropriate. 6. Please send any questions to EndoRecall@Stryker.com.
Quantity in Commerce 525 devices
Distribution OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
-
-