Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 5, 2014
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, Inc. recalled CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, I… - a critical-severity action.
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, I… was recalled by Medline Industries, Inc. in March 5, 2014. Reason: Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. Th…. Check the official notice for the remedy. Verify recall #Z-1055-2014 with the FDA Devices before acting.
The recall
Medline Industries, Inc. issued this critical-severity FDA Devices recall-Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. Th….
- Critical
- severity level
- 50 units
- affected scope
- Class I
- classification
- March 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1055-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1055-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on August 14, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Medline Industries, Inc. is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 50 units.
The documented reason for this recall is: Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc. Distribution data in the federal record shows the product reached: Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
50 units
Related Recalls
6
3 from same agency
Product description
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Reason for recall
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1055-2014 |
| Date reported | March 5, 2014 |
| Date initiated | August 14, 2013 |
| Recalling firm | Medline Industries, Inc. |
| Firm location | Waukegan, IL |
| Affected scope | 50 units |
| Distribution | Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA. |
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-1055-2014) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.. Recalled by Medline Industries, Inc.. Units affected: 50 units.
Why was this product recalled? ▼
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Critical. Recall number: Z-1055-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1055-2014) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 March 5, 2014. 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.