Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported October 12, 2016
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Biocompatibles U.k., Ltd. recalled Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx on… - a low-severity action.
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx on… was recalled by Biocompatibles U.k., Ltd. in October 12, 2016. Reason: Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack. Check the official notice for the remedy. Verify recall #D-0001-2017 with the FDA Drug before acting.
The recall
Biocompatibles U.k., Ltd. issued this low-severity FDA Drug recall-Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack.
- Low
- severity level
- Class III
- classification
- October 12, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0001-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0001-2017) was formally reported on October 12, 2016, with the manufacturer initiating the action on September 7, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Biocompatibles U.k., Ltd. is listed as the recalling firm, operating out of Farnham, N/A. Federal records list the affected scope as 3,254 administration packs.
The documented reason for this recall is: Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack Distribution data in the federal record shows the product reached: Distributed nationwide. 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 - 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,254 administration packs
Related Recalls
6
0 from same agency
Product description
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Reason for recall
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0001-2017 |
| Date reported | October 12, 2016 |
| Date initiated | September 7, 2016 |
| Recalling firm | Biocompatibles U.k., Ltd. |
| Firm location | Farnham, N/A |
| Affected scope | 3,254 administration packs |
| Distribution | Distributed nationwide |
Profile values are sourced directly from the official FDA Drug 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 (D-0001-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug 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 Drug 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? ▼
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01. Recalled by Biocompatibles U.k., Ltd.. Units affected: 3,254 administration packs.
Why was this product recalled? ▼
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 12, 2016. Severity: Low. Recall number: D-0001-2017.
Where was the recalled product distributed? ▼
Distribution: Distributed nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0001-2017) against your product. Visit the official FDA Drug 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.
Nearby Recalls in This Category
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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 Drug, reported October 12, 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.