Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 20, 2016
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bayer Healthcare recalled Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PE… - a moderate-severity action.
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PE… was recalled by Bayer Healthcare in January 20, 2016. Reason: The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out o…. Check the official notice for the remedy. Verify recall #Z-0627-2016 with the FDA Devices before acting.
The recall
Bayer Healthcare issued this moderate-severity FDA Devices recall-The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out o….
- Moderate
- severity level
- 199K units
- affected scope
- Class II
- classification
- January 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0627-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0627-2016) was formally reported on January 20, 2016, with the manufacturer initiating the action on November 30, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bayer Healthcare is listed as the recalling firm, operating out of Indianola, PA. Federal records list the affected scope as 198,598, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, poten… Distribution data in the federal record shows the product reached: Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, 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
198,598
Related Recalls
6
3 from same agency
Product description
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Reason for recall
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0627-2016 |
| Date reported | January 20, 2016 |
| Date initiated | November 30, 2015 |
| Recalling firm | Bayer Healthcare |
| Firm location | Indianola, PA |
| Affected scope | 198,598 |
| Distribution | Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, 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-0627-2016) 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? ▼
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.. Recalled by Bayer Healthcare. Units affected: 198,598.
Why was this product recalled? ▼
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2016. Severity: Moderate. Recall number: Z-0627-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, 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-0627-2016) 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 January 20, 2016. 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.