Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 25, 2015
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and inse…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Teleflex Medical recalled Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the… - a moderate-severity action.
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the… was recalled by Teleflex Medical in November 25, 2015. Reason: The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneu…. Check the official notice for the remedy. Verify recall #Z-0277-2016 with the FDA Devices before acting.
The recall
Teleflex Medical issued this moderate-severity FDA Devices recall-The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneu….
- Moderate
- severity level
- Class II
- classification
- November 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0277-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0277-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on October 14, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records list the affected scope as 2050 ea..
The documented reason for this recall is: The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device. Distribution data in the federal record shows the product reached: Nationwide Distribution including the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2050 ea.
Related Recalls
6
3 from same agency
Product description
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Reason for recall
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0277-2016 |
| Date reported | November 25, 2015 |
| Date initiated | October 14, 2015 |
| Recalling firm | Teleflex Medical |
| Firm location | Research Triangle Park, NC |
| Affected scope | 2050 ea. |
| Distribution | Nationwide Distribution including the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0277-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.. Recalled by Teleflex Medical. Units affected: 2050 ea..
Why was this product recalled? ▼
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0277-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including the states of AK, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NJ, NY, NC, OH, OK, PA, TN, TX, VA, VT, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0277-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.