Churchill Medical Systems LifeGuard Non-Coring Huber… recallZ-1327-2011 · Churchill Medical Systems, Inc. · initiated Nov 16, 2010
Terminated All recalls posted in February 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Churchill Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
FDA root cause category: Vendor change control
What the company is doing
The firm, Churchill Medical/Vygon, sent an "URGENT MEDICAL DEVICE RECALL" letter dated November 16, 2010, via overnight mail to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their stock for affected product; immediately cease use and distribution and quaratine the affected product; contact Vygon's Customer Service Department at 1-800-473-5414 for a return Merchandise Authorization number; complete and return the Recall Acknowledgement and Inventory Return Form via fax to 215-390-2019 and mail return product with form to: Vygon, 103A Park Drive, Montgomeryville, PA 18936, and if the customer is a distributor, they were to provide their customers with a copy of this notification and attached form. Note: An additional follow up communication will be provided to the customers after reconciliation of the returned inventory and all inventory will be credited or replaced. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at [email protected].
Recall details
- Recall number
- Z-1327-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 16, 2010
- Posted by the FDA
- Feb 16, 2011
- Recalling firm
- Churchill Medical Systems, Inc.
- Quantity
- 72 units
- Product code
- FPA
- FDA submissions
- K013871
- Distribution
- Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.
Product description
Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234 The Lifeguard
Code information (models, lots, serial numbers)
Lot Number: 1010004
Other devices under the same FDA submission
3 devices cleared under K013871 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Lifeguard LG-20-150Navilyst Medical, Inc. · Set, administration, intravascular2 reports
- VYGON CLG-2034Vygon Corporation · Set, administration, intravascular1 report
- Lifeguard LG-20-75Navilyst Medical, Inc. · Set, administration, intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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