CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
Baker Jejunostomy Tubes: Product recalled by Teleflex Medical Europe
Teleflex Medical Europe is recalling Baker Jejunostomy Tubes, distributed nationwide in the US. The recall was initiated on 15 Mar 2018 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-1370-2018
- FDA event ID
- 79579
- Recalling firm
- Teleflex Medical Europe, Athlone
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2018
- FDA classified
- 5 Jul 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 15 Mar 2018 | Recall initiated by company | |
| 18 Apr 2018 | Published in enforcement report | +34 days |
| 5 Jul 2018 | Classified by FDA | +78 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Which lots are affected?
(a) 655300160 655316 Batch Numbers 13EG28 13HG23 (b) 655500200 655520 Batch Numbers: 13EG28
Where was it sold?
US Nationwide Distribution
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 79579This product is part of a recall event; the main page for the event is Simplastic Suprapubic Puncture Instruments: Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Simplastic Suprapubic Puncture Instruments: Product recalled | Teleflex Medical Europe | Foreign Material | Nationwide | |
| CLASS II | Rectal Catheters recalled by Teleflex Medical Europe | Teleflex Medical Europe | Foreign Material | Nationwide | |
| CLASS II | Latex Rebreathing Bags: Product recalled by Teleflex Medical Europe | Teleflex Medical Europe | Foreign Material | Nationwide |
More recalls from Teleflex Medical Europe
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rusch Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Rusch Endotracheal Tube oral/nasal Magill, High Volume recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Rusch Endotracheal Tube oral/nasal Murphy Eye, High Volume recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Rusch Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Teleflex Medical Pilling(R) Universal Shears 7 1/2" recalled | Teleflex Medical Europe | Foreign Material | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |