CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
Magic3 Intermittent Catheter recalled by C.R. Bard
C.R. Bard is recalling Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product, distributed in 14 states. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2732-2015
- FDA event ID
- 72024
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2015
- FDA classified
- 3 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 24 Aug 2015 | Recall initiated by company | |
| 3 Sep 2015 | Classified by FDA | +10 days |
| 9 Sep 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential breach of the sterile barrier packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
Where it was distributed
US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
CaliforniaFloridaIllinoisMassachusettsMinnesotaNorth CarolinaNew HampshireNew JerseyNew YorkOhioOklahomaPennsylvaniaTexasWashington
Questions about this recall
Is Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product recalled?
Yes. C.R. Bard recalled Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product on 24 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-2732-2015.
Why was it recalled?
Potential breach of the sterile barrier packaging.
Which lots are affected?
Lot Number 53621456
Where was it sold?
US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from C.R. Bard
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |