Device recall: White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally…
Class II FDA enforcement event 77063. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Lint present on sterile Operating Room Towels.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Medical Action Industries Inc started this device recall on 19 Apr 2017. The firm address in the FDA record is in Arden, NC. FDA put the recall in Class II. FDA event 77063 has 2 product records. The first FDA enforcement report date is 24 May 2017. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
AR, IN and NV.
Recalling firm
Medical Action Industries Inc, Arden, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2101-2017 | White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. | 69 cases | Class II | Ongoing | 24 May 2017 |
| Z-2102-2017 | Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. | 38 cases (3-48pk/35-20pk) | Class II | Ongoing | 24 May 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Mar 2019 | Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) | Device | Class II | 1 |
| 27 Nov 2018 | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 4 | Device | Class II | 1 |
| 11 Dec 2017 | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This O | Device | Class II | 1 |
| 3 Feb 2016 | PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, | Device | Class II | 1 |
| 12 Jun 2014 | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. | Device | Class II | 8 |
Official channels
- FDA enforcement report Z-2101-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 77063. https://recallregister.com/fda/ii/77063/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
AR, IN and NV.
- What quantity of product is in FDA event 77063?
- The event has 2 product records. The first record gives this quantity:
69 cases
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.