Codman 3000 Series Refill Set Recalled for Leaking Needles
Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device defect (leaking needle) that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set, catalog number AP-07014. The recall is due to a defect where the needle may leak from the hub/needle cannula connection. Each refill kit contains two 22 Gauge x 1.5 inch Huber Point Needles used with a 50 mL Calibrated Syringe Barrel, Tubing Set, and Stopcock for pump refills.
The affected products are used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump. The recall covers lot numbers 14B114CT, 14E011CT, and 14E366CT. These products were distributed nationwide in the United States, as well as in Canada, France, Germany, and Switzerland.
Consumers and healthcare providers should stop using the affected refill sets and contact Codman & Shurtleff, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calib
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 5,463
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot numbers: 14B114CT
- 14E011CT
- and 14E366CT
Distribution
Distributed nationwide across the United States.
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