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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
Related recalls
Same manufacturer · Codman & Shurtleff, Inc.
See all →- ModerateCodman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- ModerateCodman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
FDA (Devices) · 2014-08-20
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- ModerateBard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
- HighBecton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks
FDA (Devices) · 2020-07-29
- SevereBecton Dickinson SafeStep Huber Needle Set Recall for Tubing Cracks
FDA (Devices) · 2020-07-29